Adept & Adhesions

Key Abstracts

Adept - Clinical Abstracts

gynaecological surgery in Belgium Foidart JM, Nisolle M.

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Ease of use of icodextrin 4% solution in the reduction of adhesions following

Presented as a poster at: International Society of Gynaecological Endoscopy 14th Annual Congress, London, P6.10, 3-5 April 2005 Clinical experiences with icodextrin 4% solution in open and laparoscopic general surgery in the multicentre ARIEL registry Ommer A, Walz MK on behalf of the ARIEL registry group. Presented at: European Association of Coloproctology 5th Scientific and Annual General Meeting European Association of Coloproctology European Council of Coloproctology First Annual Meeting Geneva, O34, 16-18 September 2004 Ease of use and safety of icodextrin 4% solution in the prevention of adhesions after general surgery: experience from the multicentre ARIEL registry Menzies D, Hidalgo M, Walz M K, Duron JJ, Tonelli F. Presented at: European Association of Coloproctology 5th Scientific and Annual General Meeting European Association of Coloproctology European Council of Coloproctology First Annual Meeting Geneva, P31, 16-18 September 2004 A pilot study of adjuvant intraperitoneal 5-fluorouracil using 4% icodextrin as a novel carrier solution Hosie KB, Kerr DA, Gilbert JA, Downes M, Lakin G, Pemberton G et al. Published in: European Journal of Surgical Oncology 2003;29:254-260 Use of anti-adhesion agents in colorectal surgery focus on infection and anastomosis Parker M on behalf of the ARIEL Registry contributors. Presented at: European Association of Coloproctology 4th Annual Meeting, Barcelona 1820 September 2003. Late Breaking Abstracts 1 Colorectal cancer adhesions and chemotherapy Wilson M. Presented at: European Association of Coloproctology 4th Annual Meeting, Barcelona 1820 September 2003: Late Breaking Abstracts 3 13 11 10 9 8

European experience with icodextrin 4% solution in routine surgical practice

15

Sutton C, Menzies DM, Pouly JL, Duron JJ, Korell M, Walz MK, Minelli L, Tonelli F, Prieto C, Pascual H. Presented at: 1st European Endoscopic Surgery Week, Glasgow 15-18 June 2003. Published in: Reviews In Gynaecological Practice June ; 3 (1): O03 European experience with icodextrin 4% solution in routine surgical practice Menzies D, Parker MC, Sutton C, Duron JJ, Walz MK, Tonelli F, Pascual H, Pouly JL, Korell M, Minelli L, Prieto C. Presented at: European Council Of Coloproctology, 9th Biennial Congress, Athens, May 31-June 4 2003 Abdominal drains do not affect antiadherential efficacy of 4% icodextrin:Experimental Study Infantino A, Bruno C, Roberto G. Presented at: European Council of Coloproctology 9th Biennial Congress, Athens, May 31-June 4 2003 European experience with icodextrin 4% solution in routine surgical practice Menzies DM, Sutton C, Pouly JL, Duron JJ, Korell M, Walz MK, Minelli L, Tonelli F, Prieto C, Pascqal H. Presented at: PAX VIth International Symposium on Peritoneum, Amsterdam 10-12 April 2003. Published in: Adhesions News and Views Abstract Supplement: Symposium III Abstract III(9) Demonstrating the clinical and cost effectiveness of adhesion reduction strategies Wilson MS, Menzies D, Knight AD, Crowe AM. Published in: Colorectal Disease 2002; 4: 355-360 22 20 18 16

Adept - Preclinical Abstracts

Effects of intraperitoneal 4% icodextrin solution on the healing of bowel anastomosis and laparotomy incisions in rabbits Rodgers KE, Verco SJS, diZerega GS. Published in: Colorectal Disease 2003; 5: (4): 324-330 Prevention of chemotherapy-induced intraperitoneal adhesion formation in rats by icodextrin at a range of concentrations Conroy SE, Baines L, Rodgers K, Deviren F, Verco SJS. Published in: Gynecologic Oncology 2003; 88: 304-308

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Adhesions The SCAR Studies (the burden and risk of adhesions)

The SCAR-3 study: 5-year adhesion-related readmission risk following lower abdominal surgical procedures Parker MC, Wilson MS, Menzies D, Sunderland G, Clark DN, Knight AD and Crowe AM on behalf of the Surgical and Clinical Adhesions Research (SCAR) Group. Published online in: Colorectal Disease 2005; doi: 10.1111/j.1463-1318.2005.00857.x SCAR-3: what factors affect adhesion-related readmission risk following gynaecological surgery? Lower AM, Hawthorn R. Presented as a poster at: International Society of Gynaecological Endoscopy 14th Annual Congress, London, P4.01, 3-5 April 2005 The risks of post-operative adhesions in colorectal surgery Wilson MS on behalf of the Surgical and Clinical Adhesions Research (SCAR) group. Presented at: European Association of Coloproctology 5th Scientific and Annual General Meeting European Association of Coloproctology European Council of Coloproctology First Annual Meeting Geneva, O35, 16-18 September 2004 The risk to the patient of an adhesion-related readmission Lower AM. Presented at 30th British Congress of Obstetrics and Gynaecology, Glasgow, 7-9 July 2004 31 30 29 28

SCAR-3: Comparative risks of colorectal procedures Wilson MS on behalf of the SCAR group. Presented at: 14th Annual Meeting of The Association of Coloproctology of Great Britain and Ireland, Birmingham, 28 June 1 July 2004. Late Breaking Abstract SCAR 2 - The risk of adhesions following colorectal surgery Sunderland G on behalf of the SCAR panel.

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Presented at: European Association of Coloproctology 4th Annual Meeting, Barcelona 1820 September 2003. Published in: Late Breaking Abstracts 2 Adhesion-related readmissions following gynaecological laparoscopy or gynaecological laparotomy in Scotland. An epidemiological study of 24,046 patients Lower AM, Hawthorn RJS, Clark D, Knight AD, Crowe AM on behalf of the SCAR panel. Presented at: 19th European Society of Human Reproduction and Embryology Annual Meeting: xviii53 O-156 29th June - 2nd July 2003. Published in: Human Reprod 2003; 18 (suppl 1): 53 Adhesion-related readmissions following gynaecological laparoscopy in Scotland. An epidemiological study of 24,046 patients Hawthorn RJS, Lower A, Clark D, Knight AD, Crowe AM, on behalf of the SCAR panel. Presented at: 1st European Endoscopic Surgery Week, Glasgow 15-18 June 2003. Published in: Reviews in Gynaecological Practice, June 2003; 3 (1): 01 Adhesion related readmissions following colorectal surgery in Scotland. An epidemiological study of 4,912 patients Parker MC, Wilson MS, Menzies D, Clark D, Knight AD, Crowe AM. Presented at: European Council Of Coloproctology 9th Biennial Congress, Athens, May 31-June 4 2003 Adhesion-related readmission rates in Scotland between 1996 and 2000 Wilson M, Parker M, Menzies D, Lower A, Hawthorn R, Thompson J et al. Presented at: PAX VIth International Symposium on Peritoneum, Amsterdam 10-12 April 2003. Published in: Adhesions News and Views Abstract Supplement: Symposium VII Abstract VII(6) 43 41 39 37

The burden of adhesions - evaluating the clinical impact and the value of adhesion reduction strategies Wilson MS, Menzies D, Knight AD, Crowe AM. Presented at: European Association of Coloproctology 3rd Scientific and Annual General Meeting, Erlangen, September 2002. Abstract Workbook 3-6 The impact of adhesions following colorectal surgery today evaluating the potential impact tomorrow Parker MC, Wilson MS, Menzies D, Clark D, Ford I, Knight AD. Presented at : European Association of Coloproctology 3rd Scientific and Annual General Meeting, Erlangen, September 2002. Abstract Workbook 7-10 Adhesion related outcomes in 9,599 patients undergoing colon surgery between 1996-98 Parker MC, Wilson MS, Menzies D, Clark D, Knight AD, Crowe AM.

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Presented at: The Association of Coloproctology of Great Britain and Ireland Annual Meeting, Manchester, June 2002

Adhesions Medicolegal Considerations

Adhesion-reduction in high-risk surgery is there a need for consensus? Parker MC. Presented at: European Association of Coloproctology 5th Scientific and Annual General Meeting European Association of Coloproctology European Council of Coloproctology First Annual Meeting Geneva, O36, 16-18 September 2004 Towards a UK consensus on adhesion reduction Trew G. Presented at 30th British Congress of Obstetrics and Gynaecology, Glasgow, 7-9 July 2004 What will we tell our patients and what will we do? Parker MC. Presented at: 14th Annual Meeting of The Association of Coloproctology of Great Britain and Ireland, Birmingham, 28 June 1 July 2004. Late Breaking Abstract 53 51 50

Adept - Clinical Abstracts

Presented as a poster at: International Society of Gynaecological Endoscopy 14th Annual Congress, London, P6.10, 3-5 April 2005

Ease of use of icodextrin 4% solution in the reduction of adhesions following gynaecological surgery in Belgium
Foidart JM, Nisolle M. OBJECTIVE: To monitor ease of use and patient acceptability of icodextrin 4% solution (Adept) in routine gynecological surgery in Belgium. DESIGN AND METHODS: With the introduction of 4% icodextrin solution, the Belgium Adept Registry (BAR) was established. Gynaecologists from 22 centres evaluated its ease of use and patient acceptability in routine gynaecological surgery associated with a risk of adhesions. Anonymised data collection forms were submitted to the BAR central database. RESULTS: Routine use of icodextrin 4% solution was assessed in 199 patients (n=148 laparoscopies, n=51 laparotomies). The median volume of icodextrin 4% solution used for irrigation and instillation was 500 mL and 1000 mL respectively for both laparoscopies and laparotomies. Most surgeons rated the ease of use (viewing of surgical field, handling of tissues) of icodextrin 4% solution as excellent or good and fluid leakage from surgical sites as normal (63% of laparoscopies and 65% of laparotomies) or less than normal (19% of laparoscopies, 14% of laparotomies). Abdominal discomfort was rated as expected in 63% of laparoscopies and 73% of laparotomies, and less than expected in 29% of laparoscopies and 20% of laparotomies. Abdominal distension figures were comparable. CONCLUSIONS: Feedback from BAR indicates that icodextrin 4% solution used as an irrigant and post-operative instillate was very well tolerated by patients and contributing gynaecologists found it easy to use in surgery for the reduction of adhesions. Although side effects have not been systematically recorded in BAR, Adept overall tolerance was judged to be excellent as was substantiated by the larger pan European ARIEL registry which assessed safety in 4620 patients.

Presented at: European Association of Coloproctology 5th Scientific and Annual General Meeting European Association of Coloproctology European Council of Coloproctology First Annual Meeting Geneva, O34, 16-18 September 2004

Clinical experiences with icodextrin 4% solution in open and laparoscopic general surgery in the multicentre ARIEL registry
Ommer A, Walz MK on behalf of the ARIEL registry group. INTRODUCTION: Major abdominopelvic surgery is associated with a substantial risk and burden of adhesions. The Adept Registry for Clinical Evaluation (ARIEL) was established to evaluate the acceptability of icodextrin 4% solution (Adept) an intraoperative device approved in Europe to reduce post-surgical adhesion formation in routine surgery. PATIENTS AND METHODS: Participating surgeons assessed 1738 patients undergoing open (1469) or laparoscopic (269) general surgery (45.8% included adhesiolysis) in 103 surgical centres in 5 European countries. Ease of use, acceptability and safety of icodextrin were evaluated. RESULTS: Mean volumes of icodextrin used in open surgery were 871 ml (irrigant) and 999 ml (instillate), in line with the manufacturers recommendations (irrigant, 100ml every 30 minutes; instillate 1L). Ease of use was described as okay, good or excellent in most cases (96%). Abdominal discomfort/distension were reported to be less than or as expected in most patients (discomfort, 91%; distension, 90%). Drains were used in 698 patients (47.5%; France 42%, Germany 75%, Italy, 96%, Spain 57%, UK 37%) and most surgeons (63%) reported drain loss to be 'as expected' (mean SD; 279 312 ml). Peritonitis or intra-abdominal infections/abscess occurred in 0.27% of patients. The incidence of anastomotic leakage, in 983 open anastomotic procedures, was 2.7%. In the largest group (colorectal procedures, 761) incidences of anastomotic leakage were: right colon, 4.5%; rectum, 4.3%; unspecified 3.3%; left colon, 0%. CONCLUSION: Icodextrin 4% solution is easy to use and can be used with drains. In ARIEL, post-operative complication rates were minimal and were in line with rates published in the general surgery literature.

Presented at: European Association of Coloproctology 5th Scientific and Annual General Meeting European Association of Coloproctology European Council of Coloproctology First Annual Meeting Geneva, P31, 16-18 September 2004

Ease of use and safety of icodextrin 4% solution in the prevention of adhesions after general surgery: experience from the multicentre ARIEL registry
Menzies D, Hidalgo M, Walz M K, Duron JJ, Tonelli F. AIM: The likelihood of developing adhesions following abdominolpelvic surgery is substantial. The Adept Registry for Clinical Evaluation (ARIEL) investigated the acceptability of icodextrin 4% solution (Adept) an intra-operative device approved in Europe to reduce post-surgical adhesion formation METHOD: Surgeons from 103 European centres evaluated icodextrin for ease of use, acceptability and adverse events in 1738 patients (UK 902, Spain 440, Germany 167, France 141, Italy 88) undergoing open (1469) or laparoscopic (269) general surgery (45.8% included adhesiolysis). RESULTS: For open surgery, mean volumes of icodextrin used were 871 ml for irrigation and 999 ml for instillation. Ease of use was described as okay, good or excellent in 96% of cases. In procedures using drains (47.5%), most surgeons (63%) reported drain loss to be as expected (mean SD; 279 312 ml). Incidence of peritonitis or intra-abdominal infections/abscess in open surgery was 0.27%, postoperative ileus 3.6% and healing or infection of wound sites, 3.8%. In 983 open anastomotic procedures, 27 leaks (2.7%) were reported. Laparoscopic data will also be presented. CONCLUSION: Icodextrin 4% solution was easy to use and can be used with drains. Post-operative complication rates were in line with published literature on complications in general surgery.

Published in: European Journal of Surgical Oncology 2003;29:254-260

A pilot study of adjuvant intraperitoneal 5-flouracil using 4% icodextrin as a novel carrier solution
Hosie KB, Kerr DA, Gilbert JA, Downes M, Lakin G, Pemberton G et al. AIM: This pilot study utilised the sustained intraperitoneal (i.p.) dwell properties of an iso-osmotic solution of 4% icodextrin to investigate the tolerability, toxicity and feasibility of home-based i.p. 5FU adjuvant chemotherapy following resective surgery for colorectal cancer. METHODS: Twenty eligible patients (Dukes' stage B and C with potentially curative resection) underwent perioperative Tenckhoff catheter placement. Ten (6 male, 4 female, aged 46-85; mean 67.5 years) received 5FU chemotherapy. After initial flushing and gradual increase in volumes of 4% icodextrin alone, patients received home-based i.p. 5FU (150-300 mg/m(2)/day given as equal doses at 12-hourly intervals) for 14 days, with a 14-day recovery period, for a maximum of 6 courses. Two incurable patients, treated on compassionate grounds, provided further safety data. RESULTS: Nine of the 10 patients became proficient in self-treatment with 5FU and two completed 6 courses. Frequent abdominal pain was the main dose-limiting toxicity of 5FU, causing withdrawal of three patients after a high (300 mg/m(2)/day) first course and one following a third course at lower doses. I.p. 5FU concentrations (mean>30000 ngml(-1)) were 1000 fold higher than systemic venous levels. Bacterial peritonitis led to two withdrawals but was not a frequent event (microbiologically confirmed incidence of 1 per 27 catheter-months). CONCLUSIONS: Home-based i.p. adjuvant chemotherapy is a feasible treatment option in patients with surgically resected colorectal carcinoma.

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Presented at: European Association of Coloproctology 4th Annual Meeting, Barcelona 1820 September 2003. Late Breaking Abstracts 1

Use of anti-adhesion agents in colorectal surgery focus on infection and anastomosis

Parker M on behalf of the ARIEL Registry contributors. BACKGROUND: Adhesions are an almost inevitable consequence after major abdominal surgery. The SCAR study demonstrated the particularly high risk of adhesion-related disease after colorectal surgery1. The rate of re-operative surgery after initial colorectal surgery is high with associated complications such as inadvertent enterotomy2,3. There is thus a clear need for the use of an effective anti-adhesion agent to reduce the formation of adhesions in colorectal surgery. For any agent to be adopted for use it should reduce adhesions and related complications but be easy to use, inexpensive and have a good safety profile. Colorectal surgeons live in fear of anastomotic leaks and while the adage that there are good adhesions (those that form around the anastomosis) and bad adhesions (those adhesions that form everywhere else) is a misnomer a key factor for any colorectal surgeon is to know that use of an anti-adhesion agent is not going to pose more problems than it could potentially prevent. With the introduction of 4% icodextrin solution (Adept), alongside an ongoing and rigorous clinical research programme, the opportunity for systematic tracking of early usage was proposed by a number of adhesion specialists. It was important in an area where many agents have fallen out of use because of handling difficulties, safety, patient acceptability problems and high costs. ARIEL (Adept Registry for Clinical Evaluation) is a European registry designed to provide systematic tracking and feedback on the use of 4% icodextrin solution (Adept) as an adhesion-reduction agent. RESULTS: As of July 2003, 640 patients undergoing general surgery have been included in the database. This number is increasing steadily and provides important feedback on the acceptability and safety of using Adept in routine surgery. Most surgeons scored their overall satisfaction, viewing and handling of Adept as good (74%, 70%, 71% laparotomy; 87%, 91%, 83% laparoscopy). Patient abdominal discomfort was reported as less than normal or as normal in 89% of laparotomies and laparoscopies. Preclinical work with 4% icodextrin solution has established that there is no difference in anastomotic leak rate compared with either lactated Ringers Continued on following page...

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solution or surgery alone4. Initial analysis of ARIEL Registry feedback on patients undergoing open surgery where an anastomosis was formed, indicates a leak rate of 2.9% which is close to the 46% rates most frequently reported in a recent systematic review of anastomotic leaks after gastrointestinal surgery5. This and other safety aspects of the use of Adept are being rigorously monitored. Reported adverse incidents from ARIEL Registry contributors (solicited reports) and spontaneous reporting are reassuringly low and consistent with those expected for a peritoneal instillate. References:
1. Parker MC, Ellis H, Moran BJ et al. Postoperative adhesions: Ten-year follow-up of 12,584 patients undergoing lower abdominal surgery. Dis Colon Rectum 2001; 44: 82230. 2. Coleman MG, McLain AD, Moran BJ. Impact of previous surgery on time taken for incision and division of adhesions during laparotomy. Dis Colon Rectum 2000; 43: 12979. 3. Van der Krabben AA, Dijkstra FR, Nieuwenhuijzen M et al. Morbidity and mortality of inadvertent enterotomy during adhesiotomy. Br J Surg 2000; 87: 46771. 4. Rodgers KE, Verco SJS, diZerega GS. Effects of intraperitoneal 4% icodextrin solution on the healing of bowel anastomoses and laparotomy incisions in rabbits. Colorectal Dis 2003; 5: 32430. 5. Bruce J, Krokowski ZH, Al-Khairy G et al. Systematic review of the definition and measurement of anastamotic leak after gastrointestinal surgery. Br J Surg 2001; 88: 115768.

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Presented at: European Association of Coloproctology 4th Annual Meeting, Barcelona 1820 September 2003: Late Breaking Abstracts 3

Colorectal cancer adhesions and chemotherapy

Wilson M. DISCUSSION: In spite of the improvements in the treatment of colorectal cancer over the past few years, there continues however, to be a significant number of individuals who suffer from tumours that recur within the peritoneal cavity who are not suitable for further therapy. These patients suffer from a very poor quality of life and will often die as a result of malignant bowel obstruction. The use of intraperitoneal chemotherapy has been investigated in the management of ovarian cancers and there is evidence that this leads to better cytotoxicity. Intraperitoneal instillation of agents such as cisplatin and paclitaxel has been shown to increase the local availability of these agents by up to 1000 times compared with systemic delivery. Phase II studies have reported complete responses in patients who had previously relapsed after first line systemic chemotherapy. There are now some early indications that intraperitoneal hyperthermic chemotherapy after complete surgical cytoreduction can lead to significant improvements in quality of life as well as long term survival in patients with bulky peritoneal carcinomatosis of gastrointestinal origin. In addition to improving the control of peritoneal disease, there is evidence that the absorption of the chemotherapeutic agent into the portal blood reduces the formation of hepatic micrometastases. Preclinical data show that much of the capillary system associated with the first microscopic cancerous deposits comes from the portal vein. As drug uptake from the peritoneal cavity largely occurs through the portal system, intraperitoneal chemotherapy may be an effective adjunct in those gastrointestinal cancers associated with a high risk of hepatic spread. Central to this form of therapy is the mode of drug delivery to the peritoneum. There is a need to use an agent which is non-toxic and non-irritating to the peritoneum, that can be used in patients with cancer and one that is slowly absorbed in order to allow the active drug to be exposed to the peritoneum for as long as possible. It needs to be stable when heated and in order for the drug to circulate freely post-operatively it would be of great advantage if the formation of adhesions were limited. 4% icodextrin solution is a good candidate for this type of therapy as it fulfils all of the above criteria and has a very good safety profile of use within the abdominal cavity. Continued on following page... 13

The challenge is first to confirm that this type of therapy is feasible and then to go on to perform prospective randomised studies to see if this approach is the next weapon to use in the battle against colorectal cancer.

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Presented at: 1st European Endoscopic Surgery Week, Glasgow 15-18 June 2003. Published in: Reviews In Gynaecological Practice June ; 3 (1): O03

European experience with icodextrin 4% solution in routine surgical practice

Sutton C, Menzies DM, Pouly JL, Duron JJ, Korell M, Walz MK, Minelli L, Tonelli F, Prieto C, Pascual H. AIM: When introducing a new procedure or agent into routine surgery it is clinically responsible to monitor use and not simply rely on clinical trial experience. Icodextrin 4% solution (Adept) has Europe-wide approval as an adhesion-reduction solution and is in routine use in many European centres. Alongside an ongoing and rigorous clinical research programme, the opportunity for systematic tracking of early usage was proposed by leading adhesion specialists as important in an area where many agents have fallen out of use because of handling difficulties, patient acceptability problems and high costs. METHODS: Following an initial pilot in the UK a European Registry (ARIEL) was established to allow for systematic tracking and feedback of Adept use in routine laparoscopic and open gynaecological and general surgery as an irrigant and/or postoperative instillate for the reduction of adhesions. A wide array of information is recorded including: surgery undertaken; Adept use; surgeon and patient experiences, and adverse events. Anonymised data submitted centrally allows for close monitoring of early use as well as inter-centre and inter-country comparisons. RESULTS: The initial pilot identified the need for a 1.5 L presentation of Adept particularly in laparoscopic surgery. Over 270 centres have been recruited to ARIEL to provide potential feedback on over 7,000 patients (~4,000 Gynaecological and ~3,000 General Surgery). Data on the first 491 laparoscopy patients indicate that 87.4% felt the use of Adept was good to excellent in terms of overall satisfaction (ease of use, viewing operative site and handling). In relation to patient abdominal discomfort associated with a post operative instillate this was scored as what would be normally expected or less than expected by 89.1%. ARIEL data is received regularly and updated monthly, latest data will be presented. CONCLUSIONS: The ARIEL Registry will provide the largest body of experience of an adhesion reduction agent in routine surgery, providing vital information on the acceptability of 4% icodextrin solution to surgeons and patients. It also provides an optimal pharmacovigilance tool to monitor potential complications. Initial data suggests Adept is very well received by surgeons and patients as part of routine surgery. 15

Presented at: European Council Of Coloproctology, 9th Biennial Congress, Athens, May 31-June 4 2003

European experience with icodextrin 4% solution in routine surgical practice

Menzies D, Parker MC, Sutton C, Duron JJ, Walz MK, Tonelli F, Pascual H, Pouly JL, Korell M, Minelli L, Prieto C. AIM: When introducing a new procedure or agent into routine surgery it is clinically responsible to monitor use and not simply rely on clinical trial experience. Icodextrin 4% solution (Adept) has Europe-wide approval as an adhesion-reduction solution and is in routine use in many European centres. Alongside an ongoing and rigorous clinical research programme, the opportunity for systematic tracking of early usage was proposed by leading adhesion specialists as important in an area where many agents have fallen out of use because of handling difficulties, safety, patient acceptability problems and high costs. METHODS: Following an initial pilot in the UK a European Registry (ARIEL Adept Registry for Clinical Evaluation) was established to allow for systematic tracking and feedback of Adept use in routine open and laparoscopic general and gynaecological surgery as an irrigant and/or postoperative instillate for the reduction of adhesions. A wide array of information is recorded including: surgery undertaken; Adept use; surgeon and patient experiences, use of drains and adverse events. Anonymised data submitted centrally allows for close monitoring of early use as well as inter-centre and inter-country comparisons. RESULTS: The initial pilot provided useful information on use of Adept in patients with drains. 26% of surgeons reported drain loss as greater than expected while 64% reported it as expected. The median reported loss was 300ml which happened in the first 60 minutes after drain insertion 30% of the one litre postoperative instillate. With around 600ml remaining this pilot information suggests Adept can be used with drains supporting anecdotal experience. Further information will be obtained from the expanded Registry alongside formalised research. The pilot also identified the need for a 1.5 L presentation of Adept particularly in laparoscopic surgery. Over 270 centres have now been recruited to ARIEL to provide potential feedback on over 7,000 patients (3,000 General Surgery). Data on the first 263 General Surgery patients indicated that in terms of overall satisfaction (ease of use, viewing operative site and handling) none of the contributing surgeons was dissatisfied with Adept use and 94.3% were satisfied/very satisfied (5.73% not recorded). In relation to patient 16 Continued on following page...

abdominal discomfort associated with a post operative instillate this was scored as what would be normally expected or less than expected by 84.4% - only 1.9% reported some clinical concern. ARIEL data is received regularly and updated monthly, latest data will be presented. CONCLUSIONS: The ARIEL Registry will provide the largest body of experience of an adhesion reduction agent in routine surgery, providing vital information on the acceptability of 4% icodextrin solution to surgeons and patients. It also provides an optimal Pharmacovigilance tool to monitor potential complications. Initial data suggests Adept is very well received by surgeons and patients as part of routine surgery.

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Presented at: European Council of Coloproctology 9th Biennial Congress, Athens, May 31-June 4 2003

Abdominal drains do not affect antiadherential efficacy of 4% icodextrin: Experimental Study

Infantino A, Bruno C, Roberto G. BACKGROUND: Peritoneal adhesions represent a problem of clinical relevance and economic impact. About two thirds of intestinal occlusions and sub-occlusions after abdominal and pelvic surgery are caused by adhesions. A non-viscous anti-adhesion solution of 4% icodextrin (Adept, Shire, UK), based on the principle of hydroflotation, has been developed. A randomised, multicentric study showed that 4% icodextrin is well tolerated and reduces adhesions formation; the recent literature confirms that also its chronic use and at a higher concentration (7.5%) is very well tolerated. A database on the use of 4% icodextrin showed that 26.2% of surgeons refer a loss of liquid through the drains higher than expected, roughly equal to 30% of the used amount. To better evaluate whether a decrease of icodextrin efficacy could be related to its loss through the drains, a preclinical pilot study was conducted on rabbits. METHODS: Twenty male rabbits, divided into 4 groups (5 rabbits per group), underwent, in general anaesthesia, median laparotomy with subsequent ileal resection and termino-terminal anastomosis; the peritoneum of a portion of ascending colon and ileum around the anastomosis was then removed. Group 1: Icodextrin 4% (50 ml) was introduced in the peritoneal cavity and 2 clamped drains, open every 24 hours for 3 hours during the first 3 days following surgery, were positioned; the leaked liquid was collected. Drains were removed after 3 days. Group 2: instillation of icodextrin (50 ml) and positioning of drains always maintained open. Group 3: instillation of icodextrin (50 ml), but no drains were used. Group 4: no icodextrin was instilled and no drains were used. A laparotomy was performed 15 days after surgery. The presence of adhesions was evaluated by the following score: 0= no adhesions; 1= 1 adhesion; 2= 2 adhesions; 3= 2-5 adhesions; 4= extended adhesions or death from mechanical causes due to adhesions.

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RESULTS: Total score per group was: 5 for Group 1; 7 for Group 2; 2 for Group 3 and 13 for Group 4. Loss of liquid through the drains was 19.2% of instilled icodextrin in Group 1, and 15% in Group 2. Our pilot study shows that icodextrin, 15 days after surgery, is efficacious in preventing peritoneal adhesions and reducing adhesions severity. Even though a reduced number of adhesions was observed in those animals with no drains (Group 3) compared to animals with drains (Group 1 and 2), the occurrence of adhesions seems little related to the mild liquid loss, considering the volume (50 ml) introduced during surgery. CONCLUSIONS: We conclude that 4% icodextrin is able to prevent adhesions, even when used in the presence of drains, perhaps with an effect proportional to time of contact with the peritoneum.

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Presented at: PAX VIth International Symposium on Peritoneum, Amsterdam 1012 April 2003. Published in: Adhesions News and Views Abstract Supplement: Symposium III Abstract III(9)

European experience with icodextrin 4% solution in routine surgical practice

Menzies DM, Sutton C, Pouly JL, Duron JJ, Korell M, Walz MK, Minelli L, Tonelli F, Prieto C, Pascqal H. BACKGROUND: When introducing a new procedure or agent into routine surgery it is clinically responsible to monitor use and not simply rely on experiences from clinical trials. Icodextrin 4% solution (Adept) has Europe-wide approval as an adhesion reduction solution and is now available across Europe and is in routine use in many centres. Alongside an ongoing and rigorous clinical research programme in Europe and North America, the opportunity to allow for systematic tracking and feedback of early usage was proposed by a number of leading adhesion specialists. METHODS: Following an initial pilot in the UK a European Registry (ARIEL) has been established to allow for systematic tracking and feedback of Adept use in routine open or laparoscopic general or gynaecological surgery as an irrigant and/or postoperative instillate for the reduction of adhesions. A wide array of information is recorded including: surgery undertaken; Adept use; surgeon and patient experiences; use with drains and adverse events. Anonymised data submitted to a central database allowing for close monitoring of early use across Europe as well as inter-centre and inter-country comparisons. ARIEL allows for ad hoc follow-up where patients undergo subsequent surgery. RESULTS: The initial pilot clearly identified the need for a 1.5 L presentation of Adept particularly in laparoscopic surgery. Over 250 centres are now contributing to ARIEL to provide potential feedback on over 6,000 patients (~3,500 Gynaecological and 2,500 General Surgery). ARIEL data are received regularly and updated monthly. Initial data on the first 600 patients are illustrated, latest data will be presented.

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Surgeons overall satisfaction Not recorded Type of surgery

Patient abdominal discomfort Excessive 1.1% 0.7% 2.7% <Normal <Normal 0.0% 5.6% 5.9%

Excellent

Open Gynae Laparoscopic Gynae All General Surgery

53.2% 32.6% 10.9%

2.2%

0.0%

0.0% 19.6% 75.0%

50.0% 36.3%

7.4%

0.0%

0.0%

6.3% 16.6% 73.2%

4.8% 61.3% 27.4%

0.0%

0.0%

6.5% 11.3% 69.9%

CONCLUSIONS: The ARIEL Registry will provide the largest body of experience of an adhesion-reduction agent in routine surgery, providing vital information on the acceptability of 4% icodextrin solution to surgeons and to patients. It also provides an optimal pharmacovigilance tool to monitor potential complications.

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Normal

Good

Poor

Bad

OK

Published in: Colorectal Disease 2002;4:355-360

Demonstrating the clinical and cost effectiveness of adhesion reduction strategies

Wilson MS, Menzies D, Knight AD, Crowe AM. OBJECTIVE: To examine the feasibility of conducting Randomised Controlled Trials (RCT) in lower abdominal surgery to demonstrate a reduction in adhesion-related admissions following use of an adhesion reduction product, and to model the cost effectiveness of such products. METHODS: The number of patients in each limb of a RCT comparing an adhesion reduction product to a control has been estimated based on 25% and 50% reductions in adhesion-related readmissions one year after surgery, for P = 0.05 at a power of 80% and P = 0.01 at a power of 90%. A cost effectiveness model based on the Surgical and Clinical Adhesions Research Group (SCAR) database has been developed which calculates the percentage reduction in readmissions required of an adhesion reduction product to return the cost of investment. It also estimates the cumulative costs of adhesion-related readmissions for lower abdominal surgery and the cost savings associated with an adhesion reduction policy using a low or high cost product. RESULTS: 7.2% of patients undergoing lower abdominal surgery will readmit due to adhesions in the first year after surgery. To demonstrate a 25% reduction in readmissions one year after surgery, it is calculated that a RCT would require between 5686 (P = 0.05, power = 80%) and 7766 (P = 0.01, power = 90%) lower abdominal surgery patients followed-up for one year. A cost effectiveness analysis demonstrates that routine use of adhesion reduction products costing 50 per patient will payback the cost of such investment if they reduce adhesion-related readmissions by 16% after 3 years. A product costing 200 will need to offer a 64.1% reduction in readmissions after 3 years. For the estimated 158,000 lower abdominal surgery operations conducted in the UK each year, the cumulative costs of adhesion-related readmissions over 10 years are estimated at 569 Million. CONCLUSION: Demonstrating the clinical effectiveness of adhesion reduction products in the RCT setting is unlikely to be feasible due to the large number of patients required. Products costing 200 or more are unlikely to payback their direct costs.

22

Adept - Preclinical Abstracts

23

Published in: Colorectal Disease 2003; 5 (4): 324-330

Effects of intraperitoneal 4% icodextrin solution on the healing of bowel anastomosis and laparotomy incisions in rabbits
Rodgers KE, Verco SJS, diZerega GS. OBJECTIVE: Peri-operative lavage and postoperative instillation of a 4% icodextrin solution reduces de novo formation and reformation of peritoneal adhesions following abdominal surgery. This experimental study evaluated the effects of 4% icodextrin treatment on the healing of bowel anastomoses and laparotomy incisions. MATERIALS AND METHODS: Female New Zealand White rabbits (weight 2.21-2.77 kg) were randomised by ascending weight to one of 3 surgical treatments, each with 2 termination points (6 groups of 8 animals). The treatments were anastomotic bowel surgery alone or with lavage and postoperative instillation of either 4% icodextrin solution or Lactated Ringer's Solution (LRS). The solutions were coded A and B by the supplier, so that the study personnel were blinded to their identity. After the abdomen was opened, 30 ml of solution A or B was instilled and removed by aspiration prior to surgery. The ascending colon was then transected 5 cm aboral to the ileocaecal junction and the ends anastomosed. During surgery, 5 ml of the solution was applied 4 times at the surgical site, and a further 30 ml was administered and aspirated as a postoperative lavage. Just prior to closure of the abdominal wall, 50 ml of the solution was administered as a postoperative instillate. Duplicate treatment groups were terminated 7 and 21 days after surgery and the anastomotic sites inspected for adhesion and/or abscess formation. In 6 animals per group, an 8-12 cm length of colon including the anastomotic site was removed for measurement of bursting pressure, and a section of the abdominal wall including the incision line was tested for breaking strength. The other 2 animals per group provided tissue for histological analysis of wound healing at the bowel and incision sites. RESULTS: There was no significant difference between the 3 treatment groups for any parameter (P > 0.05). Compared with the surgical control at either day 7 or 21 after surgery, the administration of solutions A or B did not affect the formation of abscesses or adhesions, the bursting strength of the bowel, or the tear strength of the abdominal wall incision. Histological assessment of the quality of wound healing showed no differences between treatment groups in inflammatory cell infiltration, fibroblast density, blood vessel formation or collagen maturity.

24

Continued on following page...

CONCLUSIONS: The use of a 4% icodextrin solution for peri-operative lavage and postoperative instillation in a rabbit model of bowel anastomotic healing did not result in any difference from either LRS treated or untreated surgical controls.

25

Published in: Gynecologic Oncology 2003;88:304-308

Prevention of chemotherapy-induced intraperitoneal adhesion formation in rats by icodextrin at a range of concentrations

Conroy SE, Baines L, Rodgers K, Deviren F, Verco SJS. OBJECTIVE: Two controlled in vivo studies in rats have investigated the effect of icodextrin solution on intraperitoneal chemotherapy-induced adhesion formation. The first study evaluated the effect of three concentrations of icodextrin (4, 15, 20% w/v) in comparison to a phosphate-buffered saline (PBS) control in response to intraperitoneal doxorubicin (n = 40). The second study compared the effect of 4% icodextrin to Ringers' lactate solution (RLS) control in response to intraperitoneal bleomycin (n = 30). METHODS: Doxorubicin and bleomycin were administered via a continuous pump and as a single bolus (bleomycin only). Doxorubicin 2 ml (23.2 g/ml) was delivered via pump in conjunction with 20 ml of 4, 15, or 20% icodextrin or PBS (n = 10 per group). In the bleomycin experiments rats received either 2 ml (0.77 U/ml) bleomycin delivered via pump in conjunction with 15 ml 4% icodextrin or RLS, or 0.77 or 0.077 U bleomycin delivered in 15 ml 4% icodextrin or RLS administered as a bolus injection (n = 5 per group). Seven days after the initiation of doxorubicin treatment and 9 days after initiation of bleomycin treatment, the rats were euthanized by CO2 and the extent of peritoneal adhesion formation was evaluated using an 8-point scoring system. RESULTS: When icodextrin was administered in conjunction with doxorubicin there was a reduction in the formation of adhesions compared to PBS. Efficacy increased with the concentration of icodextrin used. The lowest dose of bleomycin (0.077 U) caused very few adhesions. Results with bleomycin 0.77 U/ml (pump) and 0.77 U (bolus) showed that 4% icodextrin was significantly more effective than RLS at preventing adhesion formation, irrespective of the dosing regimen. CONCLUSIONS: These studies suggest that 4% icodextrin may reduce adhesion formation caused by intraperitoneal chemotherapy.

26

Adhesions The SCAR Studies (the burden and risk of adhesions)

27

Published online in: Colorectal Disease 2005; doi:10.1111/j.1463-1318.2005.00857.x

The SCAR-3 study: 5-year adhesion-related readmission risk following lower abdominal surgical procedures
Parker MC, Wilson MS, Menzies D, Sunderland G, Clark DN, Knight AD and Crowe AM on behalf of the Surgical and Clinical Adhesions Research (SCAR) Group. OBJECTIVE: The Surgical and Clinical Adhesions Research (SCAR) and SCAR-2 studies demonstrated that the burden of adhesions following lower abdominal surgery is considerable and appears to remain unchanged despite advances in strategies to prevent adhesions. In this study, we assessed the adhesion-related readmission risk directly associated with common lower abdominal surgical procedures, taking into account the effect of previous surgery, demography and concomitant disease. METHODS: Data from the Scottish National Health Service medical record linkage database were used to assess the risk of an adhesion-related readmission following open lower abdominal surgery during April 1996-March 1997. RESULTS: Patients undergoing lower abdominal surgery (excluding appendicectomy) had a 5% risk of readmission directly related to adhesions in the 5 years following surgery. Appendicectomy was associated with a lower rate of readmission (0.9%), but contributed over 7% of the total lower abdominal surgery patient readmission burden. Panproctocolectomy (15.4%), total colectomy (8.8%) and ileostomy surgery (10.6%) were associated with the highest risk of an adhesion-related readmission. Overall, the risk of readmission was doubled in patients who had undergone abdominal or pelvic surgery within 5 years of the incident operation. A higher risk of readmission was also recorded in patients aged < 60 years compared with those aged >60 years. The effect of gender was assessed. However, as the surgical codes used were found to be skewed towards women, these data have not been reported. Readmission risk was slightly higher in patients with concomitant peritonitis compared with patients without peritonitis. In contrast, Crohn's disease had no effect on risk. Patients with colorectal cancer had a lower risk of adhesion formation. However, this may have been due to the type of surgery performed in this patient group. CONCLUSION: The identification of high-risk patient subgroups may assist in effectively targeting adhesion-prevention strategies and the proffering of preoperative advice on adhesion risk.

28

Presented as a poster at: International Society of Gynaecological Endoscopy 14th Annual Congress, London, P4.01, 3-5 April 2005

SCAR-3: what factors affect adhesion-related readmission risk following gynaecological surgery?
Lower AM, Hawthorn R. OBJECTIVES: To determine adhesion-related readmission risk during 5 years following laparoscopic gynaecological surgery and to assess the influence of previous abdominopelvic surgery, surgery type, and concomitant disease, on risk. DESIGN AND METHODS: This epidemiological study used data from the Scottish National Health Service medical record linkage database to determine an incident cohort of patients undergoing laparoscopic surgery during 1996-1997. These patients were followed up for adhesion related readmissions over a 5-year period. Readmissions were identified using surgical codes selected from the Office of Population Censuses and Surveys, Fourth Edition (OPSC4) and diagnostic codes from the International Code of Diseases, Tenth Edition (ICD10). RESULTS: A total of 6,276 laparoscopic procedures (excluding sterilisations) were conducted in Scotland during 1996-1997 and 33% of patients had undergone surgery within the previous 5 years. Diagnoses at the time of surgery included endometriosis (18%), inflammatory disease of the female genitalia (12%) and pain (33%). The overall risk of a direct adhesion-related readmission within 5 years was 2.5%. This increased to 3.5% in patients that had previously undergone abdominopelvic surgery. Concomitant endometriosis and inflammatory disease did not increase readmission risk. However, ahesiolysis, which occurred in 4% of procedures, was associated with the highest risk of readmission; patients who had previously undergone surgery and subsequently underwent adhesiolysis had a risk of readmission of 6.8%. CONCLUSIONS: This study indicates that adhesiolysis procedures and previous abdominopelvic surgery are associated with an increased risk of adhesions following laparoscopic gynaecological surgery.

29

Presented at: European Association of Coloproctology 5th Scientific and Annual General Meeting European Association of Coloproctology European Council of Coloproctology First Annual Meeting Geneva, O35, 16-18 September 2004

The risks of post-operative adhesions in colorectal surgery

Wilson MS on behalf of the Surgical and Clinical Adhesions Research (SCAR) group. INTRODUCTION: The burden of adhesion-related readmissions following lower abdominal surgery remains unchanged1. This study identifies the surgical procedures associated with the greatest risk of adhesion-related readmission, and assesses the effects of previous surgery, age and concomitant disease (cancer, peritonitis) on readmission risk. PATIENTS AND METHODS: Patients undergoing open lower abdominal surgery in 1996/1997 were followed up for 5 years using the Scottish Patient Record Linkage Database. Data were analysed on a patient readmission basis. RESULTS: 12,756 patients who underwent lower abdominal surgery were identified. Within 5 years, 3.8% were readmitted with problems directly related to adhesions. Surgery within the previous 5 years increased the risk of readmission (5.8% vs. 2.5%); the risk further increased in patients aged < 60 years old (8.5%), or those < 60 years old and female (9.4%). Excision of the colo-rectum led to a risk of readmission directly related to adhesions of 11.7% which in combination with peritonitis increased to 14.3% over 5 years. CONCLUSIONS: Adhesion-related readmissions following lower abdominal surgery may be more common in a number of patient sub-groups. Patients who have undergone previous abdominal surgery, those aged < 60 years, and those undergoing colorectal surgery all appear to have a greater risk; in addition, females may be at higher risk than males. Identification of these sub-groups may enable adhesionreduction strategies to be targeted more effectively and may help to improve awareness of which patients are most likely to be affected by adhesions.
References: 1. Sunderland G. SCAR2 The risk of Adhesions Following Colorectal Surgery. Colorectal Dis 2003; 5: 598. LBA2 (Abstr.).

30

Presented at 30th British Congress of Obstetrics and Gynaecology, Glasgow, 7-9 July 2004

The risk to the patient of an adhesion-related readmission

Lower AM. All surgical procedures place a patient at risk and in our increasingly litigious society, informing the patient of the benefits versus the risks is an essential part of the consent process, yet defining what is a serious or a frequently occurring risk, versus what is not, can be a difficult line to tread. Evidence-based approaches are recognised as definitive methods for defining and ordering risk, but provision of this information needs to be tailored to the individual condition and values of each patient, as well as the skills of the surgical team. These caveats can explain hospital variations in the provision of risk information, but are there certain types of serious or frequently occurring risks which we are all duty-bound to inform? The Surgical and Clinical Research (SCAR) group have undertaken key research into the epidemiology of adhesions and the risk of adhesion-related readmissions. Our initial research1 established that up to 1 in 3 patients in Scotland undergoing open gynaecological surgery in 1986 were readmitted on average 1.9 times over a 10 year period, for a problem potentially related to adhesions, or for further intra-abdominal surgery that could be complicated by adhesions from previous surgery. More recently we have examined the adhesion-related readmission risk of therapeutic and diagnostic gynaecological laparoscopy procedures2. For medium or high risk procedures conducted in 1996, the risk of an adhesion-related readmission one-year after surgery was between 1 in 70 and 1 in 80. This risk assessment was similar to the risk of a readmission for open gynaecological procedures conducted in 1996, which ranged from 1 in 50 for procedures on the ovary , to 1 in 170 for open uterine surgery. The risk of adhesion-related readmission due to laparoscopic sterilisations was comparably low at 1 in 500. These estimates excluded the risk of readmission for procedures possibly related to or complicated by adhesions and should be regarded as underestimates of the likely risks of adhesion complications faced by the patient. The finding that certain types of laparoscopic surgery conferred a similar risk of adhesion-related readmissions to open surgery, has led us to further investigate those patients at highest risk. The effects of variables and co-variables including previous surgery, age and concomitant diseases have been assessed and support the view that certain patients have an even greater risk of a direct adhesion-related readmission than already reported. 31 Continued on following page...

A review of key consent risk information provided for gynaecological procedures revealed the following; a less than 1 in 1003 risk of a serious complication due to general anaesthesia and an estimated 1 in 1000 risk of pain, bleeding, infection or damage to the bowel or bladder in sterilisation procedures. These risks are all lower than the reported risk of readmission for conditions directly related to adhesions in the year following surgery. Our research indicates that few consent forms mention adhesion complications and none include an estimate of the associated risk. Adhesion-related readmissions are a serious complication of gynaecological surgery which can lead to infertility and in the most serious cases small bowel obstruction and death. Informing patients of these risks would seem appropriate based on comparisons to other surgical risk data currently provided.
References: 1. Lower AM, Hawthorn RJS, Ellis H et al. The impact of adhesions on hospital readmissions over ten years after 8489 open gynaecological operations: an assessment from the Surgical and Clinical Adhesions Research Study. Br J Obstet Gynaecol 2000; 107: 855-862. 2. Lower AM, Hawthorn RJS, Clark D et al. Adhesion-related readmissions following gynaecological laparoscopy or laparotomy in Scotland. An epidemiological study of 24,046 patients. Human Reprod 2004; 19(8): 1877-85. 3. Addenbrookes NHS Trust, Gynaecological Services. Patient agreement to investigation of treatment: Laparoscopic sterilisation.

32

Presented at: 14th Annual Meeting of The Association of Coloproctology of Great Britain and Ireland, Birmingham, 28 June 1 July 2004. Late Breaking Abstract

SCAR-3: Comparative risks of colorectal procedures

Wilson MS on behalf of the SCAR group. INTRODUCTION: We recently reported that the burden of adhesion-related readmissions in Scotland following lower abdominal surgery in the 1990s remains unchanged.1 The objective of this study was to determine which patient subgroups and which procedures are associated with the greatest risk of an adhesion-related readmission. This may allow adhesion-reduction strategies to be targeted and patients to be better informed of these risks. METHODS: A cohort of patients undergoing lower abdominal laparotomies in 1996 / 1997 was followed up for 5 years using the Scottish Patient Record Linkage database. Adhesion-related readmissions were classified by surgical members of the SCAR (Surgical and Clinical Adhesions Research) panel as directly related or possibly related to adhesions or as procedures that could be complicated by adhesions, based on OPCS4* surgical codes and ICD10 diagnostic codes. The cohort was analysed on a patient readmission basis for the overall data, for those who had or had not undergone previous surgery, by surgical sub-category and according to the presence or absence of concomitant conditions. RESULTS: In Scotland between April 1996 and March 1997, 12,756 patients underwent open lower abdominal surgical procedures (excluding gynaecological interventions) that could result in adhesion formation. The percentages of patients who were readmitted to hospital within 5 years after surgery are shown in the table overleaf. CONCLUSIONS: These data suggest that one in 20 patients will be readmitted to hospital as a direct consequence of adhesions within 5 years of colorectal surgery. This risk doubles in patients undergoing total colectomies with or without ileostomies. Previous abdominal surgery and peritonitis at the time of surgery may increase the risk still further. Our findings show that the risks of a directly adhesion-related patient readmission are high.We have been able to define certain patient groups for whom the risk is greatest and who should be considered for anti-adhesion therapies.
*OPCS4, Office of Population Censuses and Surveys, Fourth Edition. ICD10, International Classification of Diseases,Tenth Edition.

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Continued on following page...

Surgical category Directly related All patients (n=12756) Colon (n=3176) Total colectomies/ileostomies - with peritonitis - with colorectal cancer Right hemicolectomies (ALL) - with peritonitis - with colorectal cancer Left hemicolectomies (ALL) - with peritonitis - with colorectal cancer Rectum (n=1690) Excision of rectum - with peritonitis - with colorectal cancer 3.8 5.0 11.7 14.3 4.0 3.8 2.9 2.9 4.9 10.5 5.0 5.2 5.6 6.4 5.2

Adhesion-related readmissions within 5 years of surgery (%) Possibly related 11.6 13.6 20.5 14.3 10.0 14.3 11.4 13.9 11.8 21.1 11.4 12.2 12.5 10.4 13.5 Complicated by adhesions 6.1 8.4 15.9 7.1 12.0 4.5 2.9 4.9 8.8 13.2 5.2 15.7 15.7 27.2 13.3

Reference: 1. Sunderland G. SCAR2 The risk of Adhesions Following Colorectal Surgery. Colorectal Dis 2003; 5: 598. LBA2 (Abstr.).

34

Presented at: European Association of Coloproctology 4th Annual Meeting, Barcelona 1820 September 2003. Published in: Late Breaking Abstracts 2

SCAR 2 - The risk of adhesions following colorectal surgery

G Sunderland on behalf of the SCAR Panel. BACKGROUND: Adhesions occur in 95% of patients following lower abdominal surgery. In most cases their consequences are silent, but epidemiological research by the SCAR group1 suggest that up to 7% of patients undergoing lower abdominal surgery will be readmitted directly due to adhesions in the 10-year period following surgery. Furthermore, a substantially larger number of other readmissions will be related to adhesions e.g. pain or small bowel obstruction. The SCAR group have considered the problems of designing adhesion-related outcome trials and demonstrated that a randomised controlled trial with over 5000 lower abdominal surgery patients completing a one year follow-up would be required to demonstrate a 25% reduction in readmissions2. To establish the feasibility of undertaking such a study, updated epidemiological research using the Scottish morbidity record system has been conducted. We report on a colorectal sub-section of this research and the wider consequences of these and other data on the implications for a trial examining the effect of 4% icodextrin solution (Adept) on the rate of adhesion-related readmissions. RESULTS: A cohort of 4912 patients undergoing colorectal surgery in 1996/1997 was identified and all subsequent adhesion-related readmissions followed. The cumulative number of adhesion-related readmissions in the 4 years following surgery are shown in Table 1. In the first year following colorectal surgery these readmissions were directly related in 103 patients (2.1%) and directly/possibly related in 418 patients (8.5%). This demonstrates that up to 45% of patients will be readmitted more than once in the first year due to adhesion-related problems. Readmission rates 1 year following surgery were very similar for the consecutive cohort years 97/98 and 98/99. This research confirms the earlier SCAR study findings and suggests that adhesion-related readmissions following colorectal surgery remain a consistent problem in Scotland over the last 10 years, a fact also reflected in readmission data for all lower abdominal surgery. These findings also suggest that the Scottish Medical Record Linkage System can be utilised to follow-up a large cohort of patients as part of a clinical trial or an adhesion-reduction initiative. We are actively working to establish a clinical outcomes study with Adept. This would be one of the largest surgical studies ever and one that could be undertaken uniquely in Scotland. Further details will be presented. 35 Continued on following page...

Table 1. Cumulative number of adhesion-related readmissions in the 4 years following surgery.

Surgery type

No. of initial patients 4,912

Cumulative no. and % of adhesion-related readmissions in years following surgery Year 1 Year 2 Year 3 Year 4

Colorectal surgery 1) Directly 2) Directly/Possibly

136 2.8% 608 12.4%

212 4.3% 959 19.5%

287 5.8% 1262 25.7%

325 6.6% 1459 29.7%

References:
1. Parker MC, Ellis H, Moran BJ et al. Postoperative adhesions: Ten year follow-up of 12,584 patients undergoing lower abdominal surgery. Dis Colon Rectum 2001; 44: 82230. 2. Wilson MS, Menzies D, Knight AD, Crowe AM. Demonstrating the clinical and cost effectiveness of adhesion reduction strategies. Colorectal Dis 2002; 4: 35560.

36

Presented at: 19th European Society of Human Reproduction and Embryology Annual Meeting: xviii53 O-156 29th June - 2nd July 2003. Published in: Human Reprod 2003;18 (suppl 1): 53

Adhesion-related readmissions following gynaecological laparoscopy or gynaecological laparotomy in Scotland. An epidemiological study of 24,046 patients
Lower AM, Hawthorn RJS, Clark D, Knight AD, Crowe AM on behalf of the SCAR panel. INTRODUCTION: Adhesions are a significant cause of female infertility. Our previous research examined the burden of adhesion-related readmissions following gynaecological laparotomies conducted in Scotland in 1986. Laparoscopic surgery was in its relative infancy at the time and adhesion-related admission data were not readily identifiable. The objective of this study was to determine and compare the epidemiology of adhesion-related readmissions for gynaecological laparoscopy and laparotomy undertaken in the same year. MATERIALS AND METHODS: The Scottish morbidity record system was used to identify all gynaecological laparoscopic and laparotomy procedures (excluding caesarians) conducted in the financial year March 1996 to April 1997 and then track all adhesion-related readmissions. Laparoscopic procedures were subdivided into high risk (adhesiolysis procedures), low risk (fallopian tube sterilisation procedures), medium risk (all other procedures). Laparotomy procedures were subdivided by operation site. Adhesion-related readmissions in the subsequent four years following the initial operations were identified using OPCS4 surgical and ICD10 disease codes and categorised as either directly related, possibly related or operations not caused by adhesions but potentially complicated by them. RESULTS: A cohort of 15,197 patients undergoing laparoscopic procedures and 8,849 patients undergoing laparotomy procedures were identified. The cumulative number of readmissions either directly or possibly related to adhesions in the one to four year period following surgery are detailed below and also presented as a percentage of the initial number of surgical procedures.

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Continued on following page...

Surgery type

No. of initial Patients

Cumulative no. and % of direct or possible adhesion related readmissions in years following surgery Year 1 Year 2 Year 3 Year 4

Laparoscopy - High risk - Medium risk - Low risk - OVERALL Laparotomy - Fallopian tube - Ovary - Uterus - Vagina - OVERALL 466 328 8024 31 8849 72 15.5% 59 18.0% 442 0 573 5.5% 0.0% 6.5% 705 5571 8921 15197 110 15.6% 586 10.5% 267 963 3.0% 6.3% 160 22.7% 922 16.6% 526 5.9%

203 28.8%
1203 21.6% 743 8.3%

254 36.0% 1491 26.8% 930 10.4% 2675 17.6%

1608 10.6%

2149 14.1%

118 25.3%
94 28.7% 716 0 8.9% 0%

155 33.3% 133 40.5% 928 11.6% 3 9.7%

178 38.2% 166 50.6% 1115 13.9% 3 9.7%

928 10.5%

1219 13.8%

1462 16.5%

The number and percentage of patients readmitting one year following laparoscopic surgery were 792 (5.2%) and 433 (4.9%) following laparotomies. CONCLUSIONS: It is widely assumed that laparoscopic procedures result in fewer adhesions than laparotomies. These data support this view for laparoscopic sterilisation procedures, which form the majority of laparoscopic procedures in Scotland. Other laparoscopic procedures do however have a rate of adhesion-related readmission which is at least comparable to that for laparotomy procedures. Thus for women wishing to conceive and particularly when performing surgery of the tubes and ovaries, routine surgical practice should adopt appropriate adhesion reduction strategies. Not only may this improve pregnancy rates - but it will also reduce the wider burden of adhesion-related readmissions including pain and small bowel obstruction. Reoperative complications associated with adhesions are a rising cause of medicolegal litigation and may also be reduced.

38

Presented at: 1st European Endoscopic Surgery Week, Glasgow 15-18 June 2003. Published in: Reviews in Gynaecological Practice, June 2003; 3 (1): 01

Adhesion-related readmissions following gynaecological laparoscopy in Scotland. An epidemiological study of 24,046 patients
Hawthorn RJS, Lower A, Clark D, Knight AD, Crowe AM, on behalf of the SCAR panel. AIM: Our previous research examined the burden of adhesions following gynaecological laparotomies undertaken in Scotland in 1986 when laparoscopic surgery was in its relative infancy. The objective of this study was to determine and compare the current epidemiology of adhesion-related readmissions for gynaecological laparoscopy and laparotomy. METHODS: From the Scottish morbidity record system we identified all gynaecological surgery (excluding caesareans) conducted in the financial year March 1996 to April 1997 and tracked subsequent adhesion-related readmissions until 2001. Laparoscopies were subdivided into high risk (adhesiolysis), low risk (tubal sterilisation), medium risk (all other procedures). Laparotomies were subdivided by operative site. Adhesionrelated readmissions were identified and categorised as either directly or possibly related, or operations not adhesion related but potentially complicated by them. RESULTS: A cohort of 15,197 patients undergoing laparoscopies and 8,849 patients undergoing laparotomies were identified. The cumulative number of readmissions and percentage of the initial surgical procedures directly/possibly related to adhesions in the four year period following surgery were identified. For the 705 high risk laparoscopies undertaken in 1996/97 there were 254 (36%) adhesion-related readmissions in the subsequent four years. For medium risk (5571) and low risk (8921) laparoscopy there were 1492 (26.8%) and 930 (10.4%) readmissions 2675 (17.6%) overall. For laparotomy patients, of the fallopian tube cohort (466) there were 178 (38.2%) readmissions compared to ovary (328) 166 (50.6%); uterus (8024) 1115 (13.9%) and vagina (31) 2 (9.7%) 1462 (16.5%) overall. CONCLUSIONS: It is widely assumed that laparoscopic procedures result in fewer adhesions than laparotomies. While these data support this view for laparoscopic sterilisations, which form the majority of laparoscopies in Scotland, other laparoscopic procedures do however have a rate of adhesion-related readmission at least comparable to that for laparotomies. Thus for women wishing to conceive, and particularly for surgery of the tubes and ovaries, surgical practice should adopt routine 39 Continued on following page...

adhesion reduction strategies. Not only may this improve pregnancy rates - but will also reduce the wider burden of adhesions including pain and small bowel obstruction. Reoperative complications associated with adhesions and laparoscopic surgery are a rising cause of medico-legal litigation which may also be reduced.

40

Presented at: European Council Of Coloproctology 9th Biennial Congress, Athens, May 31-June 4 2003

Adhesion related readmissions following colorectal surgery in Scotland. An epidemiological study of 4,912 patients
Parker MC, Wilson MS, Menzies D, Clark D, Knight AD, Crowe AM. INTRODUCTION: Postoperative adhesions affect the health and fertility of patients, make reoperative surgery problematic and pose a significant impact on health resources. Our previous research (SCAR) demonstrated that the burden of adhesionrelated readmissions following colorectal surgery in 1986 was high. Since 1986 there have been advances in surgical techniques and anti-adhesion agents. The objective of this study was to assess the epidemiology of adhesions following colorectal surgery 10 years on. MATERIALS AND METHODS: The Scottish morbidity record system tracks all hospital readmissions on an individual patient basis. This was used to identify all patients undergoing colorectal surgery in the financial year April 1996 to March 1997 and all subsequent adhesion-related readmissions were then tracked over the following four years - categorised as either directly-related, possibly-related or operations not caused by adhesions but potentially complicated by them. RESULTS: A cohort of 4,912 colorectal patients was identified. The cumulative number of adhesion-related readmissions following surgery are presented as a percentage of the initial number of procedures in the table below.

Surgery type

No. of initial Patients 4,912

Cumulative No. and % of adhesion-related readmissions in years following surgery Year 1 Year 2 Year 3 Year 4

Colorectal surgery 1) Directly 2) Directly/Possibly 3) Directly/Possibly /Complicated

136

2.8%

212

4.3%

287

5.8%

325

6.6%

608 12.4% 1155 22.7%

959 19.5% 1674 34.1%

1262 25.7% 2088 42.5%

1459 29.7% 2354 47.9%

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Continued on following page...

The year one adhesion-related readmission data for a cohort of patients undergoing colorectal surgery in 1997/98 (N=4,906) and in 1998/99 (N=4,909) demonstrated very similar rates of readmission within each readmission category. The number and percentage of patients readmitting one year following colorectal surgery were 103 (2.1%) directly related, 418 (8.5%) direct/possibly related and 853 (17.3%) for all three categories, demonstrating that for patients readmitting, up to 31% readmit more than once in the first-year following surgery due to adhesion-related problems. CONCLUSIONS: Adhesion-related readmissions following colorectal surgery in the late 1990s remains high and although the majority of readmissions occur in the first year following surgery, readmissions in subsequent years remain a significant burden. This confirms the earlier SCAR study findings and shows that despite advances in colorectal surgery since 1986 this has had little impact on the burden of adhesions. Action on adhesions has received low priority despite the potential improvements in patient outcomes, reduced healthcare costs and theatre time. Surgeons have been awaiting RCT evidence of the impact of new anti-adhesion agents on clinical outcomes before using them but our assessment of patient numbers required in such a trial (>6,000) suggests this is impractical. Pending resolution of this problem with alternate strategies, it may be appropriate to accept the use of improvements in surrogate markers of adhesion reduction as demonstration of efficacy of the simpler less expensive anti-adhesion agents.

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Presented at: PAX VIth International Symposium on Peritoneum, Amsterdam 10-12 April 2003. Published in: Adhesions News and Views Abstract Supplement: Symposium VII Abstract VII(6)

Adhesion-related readmission rates in Scotland between 1996 and 2000

Wilson M, Parker M, Menzies D, Lower A, Hawthorn R, Thompson J et al. BACKGROUND: Adhesion-related readmissions represent a significant burden on healthcare. Despite the increasing availability of adhesion-reduction products to potentially reduce this burden their prophylactic use is limited. Recent research by the SCAR Panel suggests that robust randomised controlled trial outcome data is unlikely ever to be available. An alternative considered by the SCAR Panel is to undertake a study within a readily-available patient tracking database such as the Scottish patient record linkage database used in the original SCAR epidemiological study. This has the potential to allow for reliable and automated follow-up which could be used to determine the clinical effect of routine use of 4% icodextrin solution (Adept) on adhesion-related outcomes, if there are no significant differences in readmissions between years and the variance in readmissions rates between hospitals is not large. This analysis sought to establish this for the period 1996 to 2000. METHODS: Using OPCS 4 codes incident cohorts of patients undergoing lower abdominal surgery, gynaecological surgery, gynaecological laparoscopic surgery (high or low adhesion risk) were identified in 1996, 1997 and 1998. For each cohort time to first adhesion-related readmission identified by OPCS 4 or ICD10 codes were established over a 2 year period. For each hospital, and cohort year undergoing lower abdominal surgery the variance in the percentage of patients readmitting due to adhesions within the first year following surgery was also established. RESULTS: The incident cohorts for each year and corresponding percentage directly or possibly related readmissions were tabulated.

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Surgery type

Incident cohort numbers

% adhesion-related readmissions at one year 1996 1997 1998

1996

1997

1998

Lower abdominal surgery

13054

13265

12796

7.75%

7.86%

7.62%

Gynaecological surgery Gynaecological laparoscopy high-risk Gynaecological laparoscopy low-risk

8849

8723

8683

4.89%

4.46%

4.66%

705

852

879

11.77%

10.92%

8.76%

8921

7843

7455

2.5%

2.36%

2.37%

The variance in percentage readmissions between hospitals was lowest in lower abdominal surgery. CONCLUSIONS: Initial readmission rates due to adhesions following lower abdominal surgery or gynaecological surgery appear to be similar between years and reflect no reduction in the burden of adhesion readmissions since the original SCAR study. Highrisk laparoscopic gynaecological procedures including drainage of ovarian cysts, division of adhesions and complicated reversals of sterilisations have a higher risk but with a tendency for improvement over time.

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Presented at: European Association of Coloproctology 3rd Scientific and Annual General Meeting, Erlangen, September 2002. Abstract Workbook 3-6

The burden of adhesions - evaluating the clinical impact and the value of adhesion reduction strategies
Wilson MS, Menzies D, Knight AD, Crowe AM. NB French and Spanish translations available from Shire France and Shire Iberica INTRODUCTION: To evaluate the clinical impact and value of using an adhesion reduction strategy we examined the feasibility of conducting Randomised Controlled Trials (RCT) in lower abdominal surgery to demonstrate a reduction in adhesion-related admissions following use of an adhesion reduction product. The cost effectiveness of such products was also modeled. METHODS: The number of patients required in a RCT comparing an adhesion reduction product to a control has been estimated based on 25% and 50% reductions in adhesion-related readmissions one year after surgery. A cost effectiveness model based on the Surgical and Clinical Adhesions Research Group (SCAR) database has been developed to assess the level of reduction in adhesion-related readmissions required to return the cost of investment in an adhesion reduction strategy. The cumulative costs of adhesion-related readmissions for lower abdominal surgery and the cost savings associated with an adhesion reduction policy using a low or high cost product are also assessed. RESULTS: To demonstrate a 25% reduction in the 7.2% readmissions one year after surgery (from SCAR data), it is estimated that a RCT would require between 5,686 (P=0.05, power=80%) and 7,766 (P=0.01, power=90%) lower abdominal surgery patients followed-up for one year. A cost effectiveness analysis demonstrates that routine use of adhesion reduction products costing 50 per patient will payback the cost of such investment if they reduce adhesion-related readmissions by 16% after 3 years. A product costing 200 will need to offer a 64.1% reduction in readmissions after 3 years. For the estimated 158,000 lower abdominal surgery operations conducted in the UK each year, the cumulative costs of adhesion-related readmissions over 10 years are estimated at ~ 886 Million. DISCUSSION: Demonstrating the clinical effectiveness of adhesion reduction products in the RCT setting is unlikely to be feasible due to the large number of patients required. High priced adhesion reduction agents are unlikely to payback their direct costs. 45

Presented at : European Association of Coloproctology 3rd Scientific and Annual General Meeting, Erlangen, September 2002. Abstract Workbook 7-10

The impact of adhesions following colorectal surgery today - evaluating the potential impact tomorrow
Parker MC, Wilson MS, Menzies D, Clark D, Ford I, Knight AD. NB French and Spanish translations available from Shire France and Shire Iberica INTRODUCTION: The SCAR study showed the significant burden of adhesion-related disease. While there are a number of anti-adhesion agents available, evidence that routine use will reduce the burden of disease and be cost effective is required. Modeling work has shown that randomised controlled outcome studies require large numbers of patients. A practical approach to overcoming this is to progress a study in a surgery population with an existing, reliable follow-up mechanism. To establish the feasibility of this type of study it is necessary to identify a study population and establish the variance in adhesion-related outcomes. METHODS: Using the Scottish Record Linkage database, individual patient adhesionrelated outcomes for all patients undergoing colorectal surgery (open and laparoscopic) at 6, 12, 18 and 24 months in 1996, 1997 and 1998 have been assessed. These data has been used to identify the number of hospitals required in a cluster randomisation population study to demonstrate a reduction in adhesion-related outcomes. RESULTS: The percentage of adhesion-related readmissions classified as directly or possibly related one year after open colon surgery in Scotland in 1996 (n=3199), 1997 (n=3198) and 1998 (n=3223), are as follows; 8.5% (2.9% directly, 5.6% possibly), 9.0% (3.1%, 5.9%), 9.2% (2.7%, 6.5%). The most common directly-related reoperation was freeing of adhesions. Kaplan-Meier plots of time to first adhesion-related readmissions for these colon surgery populations will be compared by cohort year and also to larger lower abdominal surgery populations. DISCUSSION: This work provides important insight to the impact that colorectal surgery today has on adhesion-related outcomes and builds on the original work undertaken in the SCAR study. The variance of adhesion-related readmission rates at a hospital level has been used to estimate the number of patients and hospital cluster sites required to progress an outcomes study. It will allow us to confirm the viability of a population based clinical outcome study.

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Presented at: The Association of Coloproctology of Great Britain and Ireland Annual Meeting, Manchester, June 2002

Adhesion related outcomes in 9,599 patients undergoing colon surgery between 1996-98
Parker MC, Wilson MS, Menzies D, Clark D, Knight AD, Crowe AM. INTRODUCTION: The SCAR study showed the significant burden of adhesion-related disease. While there are a number of anti-adhesion agents available, evidence that routine use will reduce the burden of disease and be cost effective is required. Modeling work has shown that randomised controlled outcome studies are impractical because of the number of patients and length of follow-up required. A possible alternative is to progress a population based clinical outcome study. However it is necessary to identify a study population representative of the general surgical population. In undertaking this feasibility analysis important information on ongoing individual patient outcomes will be presented. METHODS: Using the Scottish Record Linkage database individual patient adhesionrelated outcomes for all patients undergoing colorectal surgery (open and laparoscopic) at 6, 12, 18 and 24 months in 1996, 1997 and 1998 have been assessed. These data has been used to identify the number of hospitals required in a cluster randomisation population study to demonstrate a reduction in adhesion-related outcomes. RESULTS: The percentage of adhesion-related readmissions classified as directlyrelated for patients undergoing open colon surgery in Scotland in 1996 (n=3192), 1997 (n=3189) and 1998 (n=3214), are as follows;

% directly adhesion-related readmissions since surgery Cohort Year 6 months 1998 1997 1996 1.2 1.2 1.2 12 months 2.3 2.3 2.1 18 months 2.7 2.5 2.9 24 months 3.1 3.1 3.3

Approximately 3 out of every 4 directly-related readmissions required reoperation within 12 months. The most common directly-related reoperation was freeing of adhesions. Details on hospital stays, morbidity and mortality will be presented. The adhesionrelated outcomes following open and laparoscopic surgery will be compared. 47 Continued on following page...

DISCUSSION: This work provides important insight to the impact that colorectal surgery today has on adhesion-related outcomes and builds on the original work undertaken in the SCAR study. The variance of adhesion-related readmission rates at a hospital level has been used to estimate the number of patients and hospital cluster sites required to progress an outcomes study. It will allow us to confirm the viability of a population based clinical outcome study.

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Adhesions Medicolegal Considerations

49

Presented at: European Association of Coloproctology 5th Scientific and Annual General Meeting European Association of Coloproctology European Council of Coloproctology First Annual Meeting Geneva, O36, 16-18 September 2004

Adhesion-reduction in high-risk surgery is there a need for consensus?

Parker MC. Adhesions are a major consequence of abdominopelvic surgery that occur in more than 90% of patients1 and are associated with a high risk of complications, such as small bowel obstruction and chronic pelvic pain. Surgeons have a duty of care to educate their patients concerning the risks of post-surgical adhesions to enable them to make informed decisions regarding treatment. However, a survey of UK surgical trainees in 2002 showed that only 14% routinely warn laparotomy patients of the risks of post-surgical adhesions2. Failure to provide such information can result in claims of negligence. Since 1995, the UK National Health Services Litigation Authority (NHSLA) has received 57 claims concerning intra-abdominal adhesions, of which half involved urological or general surgeons. Although an increase in claims has been acknowledged, a survey by the International Adhesions Society found that adhesions were mentioned during the consent process in only 10.4% of cases. A recent consensus in gynaecological surgery recommends that surgeons educate their patients during the consent process and consider the use of anti-adhesion agents in high-risk procedures to complement good surgical technique; these strategies were also recommended in a 1997 general surgery consensus. The introduction of new and more effective anti-adhesion agents since that date, together with evidence highlighting the considerable burden of adhesions, suggests that a new consensus would be of value in general surgery. References:
1. Menzies D, Ellis H. Intestinal obstruction from adhesions-how big is the problem? Ann R Coll Surg Engl 1990; 72 :603. 2. Nash G, Pullen A. Are current surgical trainees preventing future adhesions complications? Adhesions News & Views 2002; 2: 12.

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Presented at 30th British Congress of Obstetrics and Gynaecology, Glasgow, 7-9 July 2004

Towards a UK consensus on adhesion reduction

Trew G. Adhesions are an almost inevitable occurrence following abdominal and pelvic surgery, whether open or laparoscopic. The impact on daily living for many patients is serious and can result in small bowel obstruction, infertility, chronic pain and dyspareunia. The workload and costs to health systems, such as the UK National Health Service, is high. The most frequently adopted treatment currently is adhesiolysis. An important paradox is that adhesiolysis is complicated by further traumatic disruption and a high rate of adhesion reformation (85%) regardless of the method of adhesiolysis or the type of adhesion.1 Patients who have had previous surgery have a higher risk of adhesion-related complications and thus as part of a quality and risk management strategy, patients should be informed of the risk of adhesions as part of the consent process. However in a recent international survey adhesions were mentioned in only 10.4% of cases in the consent process. 54% of patients undergoing an adhesiolysis procedure were given some information, but only 46% were given specific information about how the adhesions were to be prevented from re-forming.2 In a recent UK survey of surgical trainees only, 14% routinely warned patients of the risk of adhesions.3 There is a rise in negligence cases relating to adhesions being reported both to the Medical Defence Union and the NHS Litigation Authority where gynaecologists represented 53% of cases.4 Case law has changed and judges are moving away from accepting what reasonable doctors might have done, to what reasonable patients might expect. There is therefore a duty of care to warn patients of all material risks (generally accepted as >1%) inherent in a proposed procedure. It is essential to enhance good, safe, medical practice and to reduce the risk of adverse effects. The use of safe and effective anti-adhesion agents should be considered in addition to good surgical practice (gentle tissue handling, avoidance of desiccation, avoidance of intestinal contents and foreign bodies, meticulous haemostasis and limited use of diathermy or suturing). There are a number of promising new anti-adhesion agents available and in development with comprehensive clinical programmes to confirm efficacy.

51

Continued on following page...

In the knowledge of the inevitability of postoperative adhesions and their serious consequences, it is time to ensure patients are advised and steps taken to protect them, including use of anti-adhesion agents, particularly in surgery known to be at high risk of adhesion formation, including: - ovarian surgery - endometriosis surgery - tubal surgery - myomectomy - adhesiolysis As surgeons we should be aware that in our increasingly litigious culture that the consequences of adhesions not only affect patients but could damage our reputation and career. Recommendations for management of adhesions recently published should now be adopted as a national policy and implemented locally to protect patients and surgeons.5
References: 1. Diamond MP, Freeman ML. Clinical implications of postsurgical adhesions. Hum Reprod Update 2001; 7: 56776. 2. Wiseman D. Obtaining informed consent: patient awareness of adhesions. Adhesions News & Views 2003; 3:10-12. 3. Nash G, Pullen A. Are current surgical trainees preventing future adhesions complications? Adhesions News & Views 2002; 2:12. 4. Ellis H. Medicolegal consequences of adhesions. Hospital Medicine 2004; 65: 348-350. 5. Trew G, Lower A. Consensus in adhesion reduction management. The Obstetrician and Gynaecologist 2004; 6: S1-16.

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Presented at: 14th Annual Meeting of The Association of Coloproctology of Great Britain and Ireland, Birmingham, 28 June 1 July 2004. Late Breaking Abstract

What will we tell our patients and what will we do?

Parker MC. Adhesions are an almost inevitable consequence of major abdominopelvic surgery developing in more than 90% of patients1 and associated with a high risk of postsurgical complications, such as small bowel obstruction and chronic pelvic pain. Despite these dangers, a 2002 survey showed that only 14% of UK surgical trainees routinely warn laparotomy patients of the risks of post-surgical adhesions.2 Surgeons have a duty of care to educate patients concerning the risks of surgery to enable them to make rational, informed decisions on whether to accept or refuse treatment. Failure to provide such information can result in claims of negligence alleging a breach of duty of care resulting in injury. Since 1995, the UK National Health Services Litigation Authority (NHSLA) has received 57 claims concerning intraabdominal adhesions amounting to 3,790,577 of which almost half involved urological or general surgeons.3 Although the increasing incidence of UK negligence claims has been acknowledged, a survey conducted by the International Adhesions Society found that adhesions were mentioned as part of the informed consent process in only 10.4% of cases. Furthermore, only 54% of adhesiolysis patients were given some information prior to treatment despite the high risks associated with this procedure.4 A consensus recently developed in gynaecological surgery recommends that surgeons should educate their patients as part of the consent process and should consider the use of antiadhesion agents to complement good surgical technique, particularly in high-risk procedures such as adhesiolysis.5 A 1997 general surgery consensus recognised the need for good surgical practice, and recommended the use of antiadhesion adjuvants.6 The introduction of new and more effective anti-adhesion agents since that date, together with the increasing body of evidence highlighting the considerable and ongoing burden of adhesions, suggest that a new consensus would be of great value in general surgery. There has been no reduction in the incidence of adhesionrelated problems in the last decade.7 Knowing the high risk of adhesion-related complications following general surgery, surgeons have a responsibility to advise their patients accordingly. With the advent of new adhesion-prevention products, surgeons should be encouraged not only to educate their patients appropriately, but also to consider the use of such agents in 53 Continued on following page...

order to stem the increasing incidence of adhesionrelated problems and ensuing medicolegal claims.
References: 1. Menzies D, Ellis H. Intestinal obstruction from adhesions-how big is the problem? Ann R Coll Surg Engl 1990; 72: 603. 2. Nash G, Pullen A. Are current surgical trainees preventing future adhesions complications? Adhesions News & Views 2002; 2: 12. 3. Ellis H. Medicolegal c onsequences of adhesions. Hospital Medicine 2004; 65: 6:13. 4. Wiseman D. Obtaining informing consent: patient awareness of Adhesions. Adhesions News & Views 2003; 4: 10-12. 5. Trew G. Consensus in adhesion reduction management. Obstetrician & Gynaecologist (Lower A, ed) 2004; 6: 11. 6. Holmdahl L, Risberg B, Beck DE et al. Adhesions: pathogenesis and prevention-panel discussion and summary. Eur J Surg 1997; 163 (Suppl. 577): 5662. 7. Sunderland G. SCAR2 The risk of Adhesions Following Colorectal Surgery. Colorectal Dis 2003; 5: 598. LBA2 (Abstr.).

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