693125

research-article2017
SRIXXX10.1177/1553350617693125Surgical InnovationVanbrugghe et al

Procedural Innovations
Surgical Innovation

Experimental Procedure of Compression

2017, Vol. 24(3) 233239
The Author(s) 2017
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Anastomosis Using Fragmented Rings: sagepub.com/journalsPermissions.nav
DOI: 10.1177/1553350617693125
https://doi.org/10.1177/1553350617693125

A Porcine Model journals.sagepub.com/home/sri

Charles Vanbrugghe, MD1, David Jrmie Birnbaum, MD1,

and Stphane Victor Berdah, Prof1

Abstract
Background. Compression anastomosis has been recently abandoned because of a nonsuperiority compared to stapling
anastomosis. Nonremoval of the rings has frequently been reported and this technique does not support a routine
use. The aim of this experimental study was to assess the feasibility of anastomosis using compression with a device
consisting of fragmented rings. Methods. A new compression device, the Anastocom, was compared to standard
double-stapled colocolonic anastomosis in 2 groups of 8 pigs. In each group, colocolonic anastomosis was performed
with a circular stapler (DST Series EEA Staplers) in 4 pigs and with the Anastocom device for the other 4 pigs. Results.
The anastomotic rings were expelled between postoperative day 7 and day 13 from the 4 animals sacrificed at day
30. The anastomosis was clean and intact in all pigs. After sacrifice, there was no difference in the bursting pressure
at day 7 (P = .226) or at day 30 (P = .885) between the 2 types of anastomosis. After sacrifice at day 7, the mean
bursting pressure values for the Anastocom and EEA anastomoses were 128.6 mm Hg (range 119-143 mm Hg) and
218.9 mm Hg (range 84-240 mm Hg), respectively. After sacrifice at day 30, the mean bursting pressure values for the
Anastocom and EEA anastomoses were 111 mm Hg (range 59-234 mm Hg) and 105 mm Hg (range 81-130 mmHg),
respectively. Conclusion. No bowel obstruction was observed with Anastocom. This fragmentation mechanism should
better prevent nonexpulsion compared to basic compression anastomosis.

Keywords
Anastocom, compression anastomosis, bursting pressure, colorectal surgery stapled anastomosis

Introduction across studies, ranging from 0% to 2% for colorectal

Colorectal surgery generally requires an anastomosis that
can be performed with 1 of 3 available techniques, namely,
hand sewing, stapling, and compression.1 The compres-
sion device does not support a routine use in fashioning
colorectal anastomoses because of its nonsuperiority in
terms of complications; moreover, postoperative occlu-
sion due to nonexpulsion of a nonfragmentable (biofrag-
mentable) ring has been reported in the literature.2-4 The
development of fragmentable rings can avoid this risk.
However, biofragmentation is hazardous. Thus, a new
device allowing the performance of compression anasto-
mosis with fragmented rings has been designed.
To date, there is still no ideal method for fashioning
anastomoses. Anastomotic strictures and leaks represent
the most serious and important complications after
colorectal resection. Factors influencing the fate of the
anastomosis are both technical (sutures should be placed
on healthy, well-vascularized tissues and without tension)
and patient-dependent. The rate of leakage has varied
anastomosis and from 0.02% to 4% for ileocolic anasto-
mosis up to 19% for colorectal or colo-anal anastomosis.5
There is no difference between manual and mechanical
anastomosis.6,7 Furthermore, anastomotic leakages have
serious long-term consequences, particularly when anas-
tomotic strictures occur, as in 20% to 30% of cases.8-11
Compression anastomosis involves the use of a device
that traps the cut ends of the transected bowel, thereby
apposing them. The device is eliminated anally once
healing is achieved, and it is either fragmented by bio-
absorption or eliminated in one piece without fragmenta-
tion. Studies on this anastomotic procedure have been
1
Aix-Marseille Universit, Marseille, France
Corresponding Author:
David Jrmie Birnbaum, Aix-Marseille Universit, C.E.R.C. (Centre
dEnseignement et de Recherche Chirurgical), Facult de Mdecine
Nord, CS80011, 51 Boulevard Pierre Dramard, 13344 Marseille
Cedex 15, France.
Email: david.birnbaum10@gmail.com
234 Surgical Innovation 24(3)
reported in both pigs and humans in the context of benign,
malignant, and inflammatory diseases, and they have
shown comparable results to other anastomosis tech-
niques (manual and mechanical stapling).12-16 The
reported rate of anastomotic strictures and anastomotic
fistulas in humans after compression anastomosis varies
between 0.8% and 4.2% and between 0.2% and 1.8%,
respectively.17
On the other hand, a review of the literature regarding
compression anastomosis indicated that compression
anastomosis has many advantages in terms of cost and
time savings compared to both stapled and sutured
anastomosis.18
The aim of this experimental study was to assess in a
pig model the feasibility and reliability of compression
anastomosis when using this new device that consists of
fragmented rings.
Materials and Methods
Animals
All procedures were conducted to ensure respect for the
European Convention on the protection of vertebrates
used for experimental or other scientific purposes. The
experiments were conducted within the C.E.R.C. (Centre
dEnseignement et de Recherche Chirurgical) at the
Faculty of Medicine in Marseille, France, with the consent
of the institutions animal ethics committee (No. 2013.55).
Sixteen sows, each weighing approximately 30 kg, were
used for this study. The arrival of the animals was planned
to be at least 48 hours before the start of the experiment,
thus giving them time to acclimate to their new environ-
ment. A clinical examination was conducted at the end of
the acclimation period, and only animals in good health
were chosen for the experiment. The animals were stabled
in individual boxes with free and unlimited access to a
water point and were fed according to their weight.
Feeding was suspended on the day before surgery.
Sample Size Calculation
The sample size of each group was calculated to test a
potential drop in bursting pressure below 100 10 mm
Hg (5 times physiological colonic pressure) when com-
pared to the initial experimental data obtained with the
Anastocom19 (SISA online software; = .05 and power
of .90).
The study population was divided into 2 groups of 8
pigs. The first 8 pigs were sacrificed after 1 week, and the
other 8 after 1 month. In each group, 4 pigs underwent a
colocolic anastomosis with a circular stapler device,
while the other 4 pigs were treated with the Anastocom
clamp.
Anastomosis Device
Two types of devices were used for this study: a new
compression anastomosis fragmented ring (Anastocom)
and a 28-mm diameter Covidien DST Series EEA stapler
incorporating Directional Stapling Technology with 4.8-
mm staples (Autosuture, United States Surgical
Corporation, Norwalk, CT).
The Anastocom device consists of 2 fragmented rings
that hold circular segments of the intestine under continu-
ous pressure, thus leading to tissue necrosis. The rings are
expelled after a few days. The implantation device for the
rings is made of plastic and stainless steel, according to
standard NF S94-090. This device is equipped with a han-
dle that allows the rings to be fixed in place during surgery
by exerting longitudinal pressure. In the same movement,
a knife was used to liberate a passage to the inside of the
rings. The initial diameter of the ring was 28 mm.
During the creation of an anastomosis, the circular
blade cuts the tissue and the peninsulas of the outer ring,
causing the detachment of the whole apparatus from the
gun (the actuator) and the separation of the female and
male rings into 4 segments. The fragmentation of the
outer part causes the subsequent fragmentation of the
inner part.
The subsequent tissue necrosis and ring fragmentation
allow the detachment of the rings in the digestive lumen
and, consequently, their evacuation in the stool after a
few days.
Surgical Procedures
All of the animals were premedicated with an intramus-
cular injection of azaperone (2 mg/kg) and ketamine (10
mg/kg) and were then anesthetized with intravenous pro-
pofol (4 mg/kg) prior to orotracheal intubation. The ani-
mals were ventilated mechanically at a frequency of 15
per minute. Anesthesia was maintained with propofol
(0.2 mg/kg/min) and sufentanyl (1 g/kg/h) using electri-
cal syringe pulses. Concomitantly with the induction of
anesthesia, a single dose of prophylactic antibiotics was
given intravenously.
The abdominal wall was prepared in strictly aseptic
conditions with povidone iodine (dermis betadine 10%).
A 10-cm midline incision was made, and a portion of the
left colon was delivered through the wound.
First Procedure.The same surgical procedure was per-
formed with the Anastocom and the stapler.
A segment of the colon was mechanically transected. The
detachable anvil was inserted into the lumen of the digestive
segment downstream and was secured by a purse-string of a
4.0 absorbable suture. The main body of the device was
introduced into the digestive tract using the other part of the
Vanbrugghe et al 235
Figure 1. Anastomose with the Anastocom.
Figure 2. Rings and anvil.
segment through a small enterotomy, upstream of the future
site of the anastomosis (Figures 1 and 2). This separate
enterotomy was performed to facilitate the surgical proce-
dure in pigs compared to a real transanal anastomosis.
With the Anastocom, the 2 rings were then fitted into
each other, thereby allowing the 2 segments to be joined
and creating the anastomosis via compression. With the
stapler, the same procedure was performed. After each
anastomosis, the devices were checked to ensure that the
circular blades had dissected uninterrupted tissue dough-
nuts. A continuous suture was then used to suture the
digestive opening that had been previously made for the
introduction of the clamp. The abdominal wall was closed
in 2 layers. No drainage was used.
Second Procedure. During a second operation (at day 7 or
day 30), the abdominal cavity was evaluated for signs of
sepsis, leaks, or bowel obstruction. A 20-cm segment of
the large bowel that spanned both sides of the anastomosis
Figure 3. Material (A) and bursting pressure test (B).
was resected and used for evaluation. The animals were
then euthanized.
Measurements
The resected colic specimen was analyzed on the back table
and bursting pressure tests were done. Anastomosis diame-
ter measurements were made using bougies of different
sizes. The anastomotic bursting pressure (ie, the pressure at
which the colon began toleak) was recorded using 20-cm
colonic segments that included the anastomosis (bursting
pressure #1). The bowel segment was immersed in a saline
solution, and air insufflation was applied with a hand air
pump. The pressure rise was recorded on a digital display.
The bursting pressure was recorded as the point when air
bubbles escaped from the anastomosis (Figure 3A and B). If
the bowel leak occurred far enough from the anastomosis, a
second bursting pressure measurement (bursting pressure
#2) was performed on a smaller bowel segment that
included the anastomosis while excluding the leak.
After opening the segment of the intestine, we visually
checked the anastomotic lines.
Results
Fourteen females and 2 males were included.
All of the animals presented with normal behaviors
and gastrointestinal tract function during the study period.
There was no significant difference in term of weight,
and no animal died prematurely.
No difficulties were encountered during surgery.
Anastocom anastomosis took more time than EEA sta-
pler anastomosis. The mean anastomosis duration was
236 Surgical Innovation 24(3)

Table 1. Characteristics of Animal and Surgical Procedures.

AnastocomDay StaplerDay 7 AnastocomDay StaplerDay 30

7 Sacrifice (n = 4) Sacrifice (n = 4) P 30 Sacrifice (n = 4) Sacrifice (n = 4) P
Preoperative death (n) 0 0 1 0 0 1
Time of anastomosis, mean 15.5 (11-20) 10.25 (10-11) .036 14.5 (10-17) 9.75 (7-12) .043
(range)
Operative duration, 48 (43-53) 29 (27-31) .071 34.25 (28-41) 33.75 (31-36) .872
minutes, mean (range)
Postoperative complications
Wall abscess (%) 1 (12.5) 0 0 2 (25)
General infection (%) 0 0 .157 0 0 .045
Evisceration (%) 0 1 (12.5) 0 0
Bowel obstruction (%) 0 0 0 0
Postoperative death (%) 0 0 0 0
Postoperative characteristics
Fistulas (n, %) 0 0 1 0 0 1
Adhesions (%)
Step 1 2 (50) 0 1 (25) 3 (75)
Step 2 2 (50) 4 (100) .102 1 (25) 1 (25) .223
Step 3 0 0 2 (50) 0
Expulsion of the ring 0 N/A n.d. 4 (100%); J7-13 N/A n.d.
(time, %)
Stenosis (%) 0 0 1 0 0 1
Diameter of anastomosis, 29.25 (29-30) 29 (28-30) .704 30 (30-30) 30 (30-30) 1
mm, mean (range)
Bursting pressure, mm 86.3 (59.1-118.5) 107 (73.7-120) .125 67 (45.6-119.5) 66.7 (50.7-83.1) .695
Hg, 10 cm, median
(range)
Bursting pressure, mm 152.25 (119-223) 173.35 (84.4-240) .226 111 (58.9-234) 104.5 (81.3-130) .885
Hg, 2 cm, median
(range)

15 minutes (range 11-20) with the Anastocom and 10
minutes (range 7-12) with the EEA stapler (P = .001).
After sacrifice on day 7, the anastomotic rings were still
present at the anastomotic site.
The anastomotic rings were expelled between 7 and 13
postoperative days from the 4 animals sacrificed at day
30. At necropsy, there was no evidence of obstruction or
peritonitis in any animal.
The anastomosis was clean and intact in all pigs.
However, for 2 animals with EEA stapler anastomosis,
we noticed an evisceration and a wall abscess. There
were no significant differences in terms of the postopera-
tive adhesions between the 2 groups.
No difference in diameter was found between the 2
types of anastomosis. The mean diameter in both groups
was 29 mm at day 7 and 30 mm at day 30 (P = .704).
The bursting pressure of the anastomosis was mea-
sured in all animals and is shown in Table 1. Colonic rup-
ture occurred out of the anastomotic line in all animals.
Two measurements were possible in all animals, first on
the 20-cm segment and second on a reduced 4-cm seg-
ment that included the anastomosis.
In group 1 (day 7 sacrifice), no difference was found
between the 2 types of anastomosis. For bursting pressure
#1, the Anastocom colonic segment leaked at a mean
value of 86.3 mm Hg (range 59.1-118.5), while the EEA
anastomoses leaked at a mean value of 173.35 mm Hg
(range 84.4-240 mm Hg; P = .125). For bursting pressure
#2, the Anastocom colonic segment leaked at a mean
value 152.25 mm Hg (range 119-223 mm Hg), and the
EEA anastomoses leaked at a mean value of 107 mm Hg
(range 73.7-120; P = .226).
In group 2 (day 30 sacrifice), no difference was found
between the 2 types of anastomosis. For bursting pressure
#1, the Anastocom colonic segment leaked at a mean value
of 111 mm Hg (range 58.9-234 mm Hg), and the EEA
anastomoses leaked at a mean value of 104.5 mm Hg
(range 81.3-130 mm Hg; P = .885). For bursting pressure
#2, the Anastocom colonic segment leaked at a mean value
of 67 mm Hg (range 45.6-119.5), and the EEA anastomo-
ses leaked at a mean value of 66.7 mm Hg (50.7-83.1; P =
.695).
After specimen opening, Anastocom anastomosis was
always less visible than EEA anastomosis (Figure 4).
Vanbrugghe et al 237
Figure 4. Macroscopic anastomosis view.
Discussion
In this study, no difference was found between Anastocom
and EEA after colocolonic anastomosis.
It is possible that biological factors might play a role by
reducing the inflammatory response during anastomotic
healing or by upregulating collagenase formation reducing
the deposition of new collagen and resulting in improved
tensile strength of the anastomosis.20 In this study, we did
not study the histology of the anastomosis because they
were all submitted to a bursting-pressure test.
There have been no cases of ring retention. The aver-
age time to expulsion was between days 7 and 13.
Nonremoval of the rings was the main reason that leads to
abandoned compression anastomosis technique.2,3 This
might be different with fragmented rings.
No postoperative anastomotic-related morbidity or
mortality was recorded. Complications unrelated to the
anastomosis arose in the EEA group. The 2 types of anas-
tomosis showed no difference in bursting pressure or
anastomotic diameter. Our results are similar to those
reported in the literature.19,21-24
Hand-sewn and stapled anastomoses represent the gold-
standard procedures for performing bowel anastomosis. To
date, different types of compression anastomosis devices
include the Biofragmentable Anastomosis Ring (BAR),
the AKA-2, the Compression Anastomosis Clip (CAC),
and the EndoCAR (Endo Compression Anastomosis
Ring). However, compression devices have been met with
limited acceptance in the surgical community because of
their narrow inner calibers, their difficult placement, and
the assembly that is required before performing the anasto-
mosis. This study was designed to compare Anastocom
with a circular stapler (DST Series EEA Stapler).
The performance of a compression anastomosis with
Anastocom is similar to the strategy traditionally used for
staplers,25 although completing an anastomosis with
Anastocom takes longer than with a circular stapler. This
difference is probably due to procedural unfamiliarity, as
this study represents its first use. Our results are similar to
those reported in the literature.26 In a study by Dyess etal,
the time to complete an intestinal anastomosis was 22
minutes with the BAR (range 5-43 minutes), 37 minutes
with sutures (range 15-90 minutes; P < .01), and 33 min-
utes with a stapler (range 12-88 minutes; P < .06).26
At day 7, the anastomosis had not completely healed,
and the rings were still in contact with the mucosa.
However, the central lumen was large enough to allow
free fecal movement, and no bowel occlusion appeared.
The rings were expelled between 7 and 13 days after sur-
gery. In a study by Kopelman etal, the mean expulsion
time for compression rings (CAR) was 8.5 days (5-11).24
The elimination of foreign anastomotic rings probably
reduced the inflammatory process associated with suture
materials and consequently reduced the occurrence of
complications such as leakage, bleeding, and strictures.27
No anastomotic leakage was found in our study. There
was neither an increased incidence of anastomotic leak-
age after the first procedure nor clinical or visual evi-
dence of leakage during the reoperation.
The bursting pressure test measures the resistance of the
anastomosis to intraluminal pressure and is the standard
approach for determining the quality of freshly completed
anastomosis procedures.28-30 The only source of pressure
within the alimentary tract arises from peristaltic activity,
which exerts an intraluminal pressure of 22 mm Hg.31 In
our study, bursting pressures exceeded the pressures typi-
cally associated with peristalsis by a factor of >5 at day 7
and day 30, indicating that the Anastocom device creates a
safe anastomosis. Schwab etal studied the anastomotic
bursting pressures for a hand-sutured, BAR and stapled
anastomoses in the human colon. Anastomoses began to
leak at a mean bursting pressure of 93 mm Hg, and the
mean pressure required to bursting the in vitro anastomo-
ses was 124 mm Hg. The study showed that BAR anasto-
moses could withstand the highest pressures before
leakage.32 Furthermore, early bursting pressures over a
wide range of 50 to 180 mm Hg have been measured in
different animal models.30 Our results are comparable with
other studies evaluating the bursting pressure.21
Cases of postoperative bowel obstruction have been
reported in the literature with both nonfragmentable and
biofragmentable rings.4,16,33 Biofragmentation is based on
the principle of oxidative biodegradation of a material.
This phenomenon depends on conditions such as the rate
of oxygen flow and the presence of microorganisms. Pain
and postoperative ileus have been described by Dauser in
a series of 62 patients.2 However, bowel obstruction with
a compression anastomosis ring occurred in his study,
likely due to difficulty in expulsion. This uncommon
complication has been reported with biofragmentable
rings at a rate of 7.9%, as reviewed in Ghitulescu etal.16
Recently, Bobkiewicz etal presented 204 patients who
underwent anastomosis with a BAR. They confirmed the
238 Surgical Innovation 24(3)
safety and efficiency of this type of anastomosis in sev-
eral indications. This technique is still an attractive alter-
native to other types of bowel anastomoses even a
persistent intestinal obstruction risk.34
We advocate practicing with fragmented rings before
surgery to avoid this risk. This practice strategy has been
used with Anastocom, and it should reduce the rate of
postoperative obstruction due to nonexpulsion.
In conclusion, the results of this preliminary feasibility
and safety study in animals should encourage further
exploration of this promising technology. Further studies
involving a larger number of animals or patients are
needed to achieve statistical significance in the results.
When a completely disposable positioning device can be
made available, it will satisfy the need for a properly
functioning device, and its use in humans should be pro-
posed. Even though compression anastomosis has been
taken off from the market, its capacity in performing
digestive anastomosis should be still studied, particularly
with this new method of fragmented rings.
Acknowledgments
The authors thank Marie-Ange Beccaris for her assistance dur-
ing surgical procedures.
Author Contributions
Study concept and design: Stphane Victor Berdah, David
Jrmie Birnbaum
Acquisition of data: Charles Vanbrugghe, David Jrmie
Birnbaum
Analysis and interpretation: Charles Vanbrugghe, David
Jrmie Birnbaum
Study supervision: Stphane Victor Berdah, David Jrmie
Birnbaum
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with
respect to the research, authorship, and/or publication of this
article.
Funding
The author(s) disclosed receipt of the following financial sup-
port for the research, authorship, and/or publication of this arti-
cle: This work was supported by a grant from AB Medica
Mery-sur-Cher, France.
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