Feasibility of an Intraluminal Bypass Device in Low Colorectal Anastomosis

Willenz, Udi; Wasserberg, Nir; Botero-Anug, Ana Maria; Greenberg, Ron

doi:10.1177/1553350615617250

Cited by 6 publications

(2 citation statements)

References 20 publications

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“…Willenz et al . [39] first tested Cologuard in a study with 12 pigs that received a low colorectal anastomosis with insertion of the device. Contrast studies, radiographs and histological studies were used to evaluate sealing quality, device positioning and tissue damage, respectively.…”

Section: Resultsmentioning

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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Section: Resultsmentioning

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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“…Recently, the development of intraluminal fecal diverting devices has garnered the attention of researchers due to its ability to avoid stoma after proctectomy. These devices, e.g., CG-100™ and Colovac™ (Colospan), require intraluminal and/or extraluminal fixation using foreign materials to maintain the device location in the colon for several days or weeks to protect the anastomotic site (3)(4)(5). Preliminary animal and human studies regarding these devices have reported positive results (3)(4)(5)(6)(7)(8)(9); however, concerns regarding the clinical and histological changes of the colonic wall which is the device fixing site by foreign materials remain, similar to gastric banding.…”

Section: Introductionmentioning

confidence: 99%

Protective effect of intraluminal fecal diverting device against colonic wall erosion induced by wrapping bands: A post-hoc pathological analysis

Kang

Kim

et al. 2022

Turk J Surg

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Objective: Materials wrapping the bowel elicits tissue erosion gradually. We experienced several bowel wall erosions with no serious clinical consequences in our two previous animal experiments aimed at the safety and efficacy of the COLO-BT developed for intra-luminal fecal diversion. We tried to find out why the erosion is safe by investigating histologic changes of the tissue. Material and Methods: Tissue slides at the COLO-BT fixing area from the subjects which had COLO-BT over three weeks acquired from our two previous animal experiments were reviewed. For the classification of the histologic change, microscopic findings were classified for six stages (from minimal change of stage 1 to severe change of stage 6). Results: A total of 26 slides of 45 subjects were reviewed in this study. Five subjects (19.2%) had stage 6 histological change; three of stage 1 (11.5%), four of stage 2 (15.4%), six of stage 3 (23.1%), three of stage 4 (11.5%), and five of stage 5 (19.2%). All subjects which had a stage 6 histologic change survived. The phenomenon from which the back of the band is passed through is replaced by a relatively stable tissue layer due to fibrosis of the necrotic cells in the stage 6 histologic change. Conclusion: We found that thanks to the sealing effect of the newly replaced layer, no leakage of the intestinal content occurs even if perforation by erosion develops according to this histologic tissue evaluation.

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Two-year follow-up results of the use of a fecal diverting device as a substitute for a defunctioning stoma

Kang

Kim

2022

Int J Colorectal Dis

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Feasibility of an Intraluminal Bypass Device in Low Colorectal Anastomosis

Abstract: The Cologuard CG-100 device efficiently reduced contact between fecal content and low colorectal anastomosis in a porcine model and is easily deployed and extracted. It holds promise for possible clinical use pending further studies.

Cited by 6 publications

References 20 publications

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

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

Protective effect of intraluminal fecal diverting device against colonic wall erosion induced by wrapping bands: A post-hoc pathological analysis

Two-year follow-up results of the use of a fecal diverting device as a substitute for a defunctioning stoma

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