https://doi.org/10.1177/1553350619834786
Surgical Innovation
1–12
© The Author(s) 2019
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DOI: 10.1177/1553350619834786
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Original Article
Introduction
Anastomotic leakage (AL) is a dreaded complication of
rectal surgery. Although the reported overall rate of leak-
ages in colorectal anastomoses ranges from 2.4% to 12%,
a much higher rate occurs in deep rectal anastomoses.
Accordingly, the rate of clinically apparent AL after low
anterior rectal resection (LAR; ≤7cm from the anal verge)
and circular double-stapled anastomosis (CDSA) without
defunctioning stoma is up to 37.5%.
1-11
Since AL may
result in life-threatening peritonitis, sepsis, and multiple
organ failure, LAR and CDSA are regularly combined
with defunctioning stoma.
Accordingly, we already evaluated in a previous trial
in a pig model
12
whether LAR and CDSA without
defunctioning stoma but with extraluminal anastomotic
application of an experimental fibrin sealant reduces AL
rate until the ninth postoperative day since this procedure
might prevent humans from defunctioning stoma, increas-
ing quality of life, and decreasing surgical costs. Thus,
834786SRI XX X 10.1177/1553350619834786Surgical InnovationWenger et al
research-article 2019
1
Asklepios Südpfalzklinik Kandel, Kandel, Germany
2
Victor Babes University of Medicine and Pharmacy, Timisoara,
Romania
3
Ethicon, a Johnson & Johnson Company, Somerville, NJ, USA
Corresponding Author:
Frank Axel Wenger, Clinic of General, Visceral and Thoracic Surgery,
Asklepios Südpfalzklinik Kandel, Luitpoldstraße 14, 76870 Kandel,
Germany
Email: charipanc@aol.com
Is Circular Fibrin Sealing of Low Rectal
Anastomosis Able to Prevent Leakage
in 21-Day Follow-up? Randomized
Experimental Trial in Pigs
Frank Axel Wenger, PhD
1,2
, Eduard Szucsik, PhD
1,2
,
Bogdan Florin Hoinoiu, PhD
2
, Anca M. Cimpean, PhD
2
,
John P. Matonick, PhD
3
, Mihai Ionac, PhD
2
, and Marius Raica, PhD
2
Abstract
Purpose. Clinically apparent anastomotic leakage (AL) after low anterior rectal resection (LAR; <7 cm from anal
verge) using circular double-stapled anastomosis without defunctioning stoma is up to 37.5%. However, it is unclear
whether there is reduction of LAR after 21 postoperative days without defunctioning stoma but with extraluminal
anastomotic application of fibrin sealant. Methods. Forty-eight-week-old pigs underwent LAR and circular double-
stapled anastomosis in end-to-end technique (descendo-rectostomy). Animals were randomized into therapy and
control group (cg). Therapy group (n = 20) received additional extraluminal circular anastomotic application of fibrin
sealant. Objective was to assess incidence of clinically apparent and nonclinically apparent leakage through the 21st
postoperative day. Remaining animals were sacrificed on the 21st day, and anastomotic region was analyzed. In case
of earlier diagnosed AL, animals were sacrificed. Results. In cg, we observed clinically and nonclinically AL in 20%
(n = 4). No animal was identified with a nonclinical-apparent leakage in this group, and all 4 animals with leakages
presented clinical signs. In the therapy group, no animal (0/20) developed clinically apparent leakage signs. There were
no leakages in this group, but 3 animals had ulcerative lesions without leak and without clinical signs. These lesions
were observed intraluminally at crossing of staple lines after 21 days. In one of these animals, incomplete leakage was
observed, blocked by fibrin sealant. Conclusion. In circular stapled colorectal anastomosis, circular fibrin glue sealant
successfully protected anastomotic intraluminal wall defects at crossing of staple lines, reducing leakage rate from 20%
to 0% (cg vs therapy group) after 21 postoperative days.
Keywords
low anterior rectal resection, pig model, circular double-stapled anastomosis, extraluminal circular anastomotic
protection, fibrin glue sealant, anastomotic leakage