Randomized clinical trial of biodegradeable intraluminal sheath to prevent anastomotic leak after stapled colorectal anastomosis

Morks, Annelien N.; Praagh, Jasper B. van; Bakker, Ilsalien S.; Hoedemaker, H. O. ten Cate; Leuvenink, Henri G. D.; Ploeg, Rutger J.; Havenga, Klaas; Etten, Boudewijn van; Lange, Jochen; Hemmer, Patrick H. J.; Burgerhof, Johannes G. M.; Sonneveld, D J A; Tanis, Pieter J.; Wegdam, Johannes A.; Jonk, A.; Holzik, M F Lutke; Bosker, Robbert J. I.; Lamme, Bas; Bilgen, Ernst Jan Spillenaar; Bremers, André J. A.; Mijle, H C van der; Hoff, Christiaan; Vries, David P. De; Logeman, F; Sietses, C.; Versluijs-Ossewaarde, F N Lesanka; Leijtens, Jeroen W. A.; Morales, Rolando Espinosa; Neijenhuis, Peter A.; Kloppenberg, F. W. H.; Schasfoort, Renske A.; Bleeker, Wim; Hess, Daniël A.; Rosman, Camiel; Wit, Fennie; Engelenburg, K C Ton van; Pronk, Apollo; Bonsing, Bert A.; Dekker, Jan Willem T.; Consten, Esther C. J.; Patijn, Gijsbert A.; Rajcs, S Bogdan; Csapó, Zsolt; Bálint, András; Harsányi, László; István, G; Horisberger, Karoline; Bader, Franz G.; Kutup, Asad; Mariette, C.; Cebrián, F

doi:10.1002/bjs.10534

Cited by 36 publications

(28 citation statements)

References 29 publications

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“…In the C-seal trial, we found a trend to more AL in C-seal patients than in non-C-seal patients. 32 However, the overall microbial composition in C-seal patients does not seem to play a role in the occurrence of AL at first. Our observations suggest that the C-seal influences the microbial composition after introduction.…”

Section: C-sealmentioning

confidence: 97%

Mucus Microbiome of Anastomotic Tissue During Surgery Has Predictive Value for Colorectal Anastomotic Leakage

Praagh¹,

Goffau

Bakker³

et al. 2019

Annals of Surgery

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AL in patients without a C-seal can be linked to the intestinal microbiota, in particular with a low microbial diversity and a higher abundance of especially mucin-degrading members of the Bacteroidaceae and Lachnospiraceae families. In C-seal patients, however, it seems that any potential protective benefits or harmful consequences of the gut microbiota composition in regard to wound healing are negated, as progression to AL is independent of the initially dominant bacterial composition.This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0.

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Section: C-sealmentioning

confidence: 97%

Mucus Microbiome of Anastomotic Tissue During Surgery Has Predictive Value for Colorectal Anastomotic Leakage

Praagh¹,

Goffau

Bakker³

et al. 2019

Annals of Surgery

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“…Diagnostic criteria for this type of colonic perforation are a round or ovoid colonic perforation, exceeding 1 cm in diameter, on the antimesenteric site of the colon; with fecalomas present in the colon protruding through the perforated site or lying within the abdominal cavity close to the colon, causing microscopic evidence of pressure necrosis or ulcers and chronic inflammation around the perforation [ 2 ]. In a few patients participating in the C-seal trial [ 3 ], we saw a similar clinical presentation. The C-seal is a biodegradable intraluminal device, which is attached proximal to a stapled colorectal anastomosis with the aim to reduce anastomotic leakage (Fig.…”

Section: Introductionmentioning

confidence: 54%

“…Because of these cases, a change was made in the protocol of the C-seal trial, after which patients had to be given oral mechanical bowel preparation before surgery in order to have an unfilled intestinal lumen or else they would be excluded. [ 3 ] After this protocol change, we did not see any perforations proximal to the anastomosis.…”

Section: Discussionmentioning

confidence: 97%

Stercoral perforation proximal to the stapled anastomosis after low anterior resection with an intraluminal device

Praagh

Bakker

Havenga

2017

Int J Colorectal Dis

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Stercoral perforation of the colon is a rare phenomenon and a potential life-threatening condition requiring acute intervention. A little more than 200 cases have been described to date. The mechanism is not completely understood. In this short communication, we present three patients with a colon perforation proximal to the anastomosis, similar to a stercoral perforation, following colorectal cancer resection with application of an intraluminal device, the C-seal.

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“…In addition, this technique involves anchoring the device to the anastomotic staple line, which may lead to traction on the anastomosis through the flexible sheath and the subsequent development of a leak. Other reported problems related to C-seal include detachment of the sheath from the anvil and double stapling to the colonic wall [35].…”

Section: Discussionmentioning

confidence: 99%

Intraluminal bypass devices as an alternative to protective ostomy for prevention of colorectal anastomotic leakage: a systematic review of the literature

et al. 2020

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Aim Anastomotic leakage (AL) is the most important complication of colorectal surgery, leading to high morbidity and mortality. Protective ostomy, the current standard of care for protecting a colorectal anastomosis, has important drawbacks that require the creation of an alternative strategy. Over the past 30 years, several intraluminal bypass devices, designed to shield the anastomosis from the faecal stream, have been developed. The aim of this literature review was to create an updated overview of the devices available and their effectiveness in preventing AL, and to investigate whether they could serve as an alternative to protective ostomy in the future. Method A systematic review of the literature on intraluminal bypass devices used for preventing colorectal AL was performed. The MEDLINE and Cochrane Library databases were searched, and articles were marked as relevant if an intraluminal bypass device was studied in an animal or human population. Results The database search yielded 24 relevant articles related to 10 intraluminal bypass devices protecting a colorectal anastomosis. These articles included experimental animal studies, preclinical (pilot) studies, as well as retrospective and prospective clinical studies. Each device was assessed with regard to surgical technique, effectiveness and device-related complications. Conclusion Intraluminal bypass devices show promise in preventing AL and its clinical consequences. However, there is insufficient high-level evidence to draw firm conclusions. There is a need for randomized controlled trials that directly compare these devices with the protective ostomy.

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Randomized clinical trial of biodegradeable intraluminal sheath to prevent anastomotic leak after stapled colorectal anastomosis

Abstract: C-seal application in stapled colorectal anastomoses does not reduce anastomotic leakage. Registration number: NTR3080 (http://www.trialregister.nl/trialreg/index.asp).

Cited by 36 publications

References 29 publications

Mucus Microbiome of Anastomotic Tissue During Surgery Has Predictive Value for Colorectal Anastomotic Leakage

Mucus Microbiome of Anastomotic Tissue During Surgery Has Predictive Value for Colorectal Anastomotic Leakage

Stercoral perforation proximal to the stapled anastomosis after low anterior resection with an intraluminal device

Intraluminal bypass devices as an alternative to protective ostomy for prevention of colorectal anastomotic leakage: a systematic review of the literature

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