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Published in: Techniques in Coloproctology 6/2019

01-06-2019 | Silicone | Original Article

Protection of colorectal anastomosis with an intraluminal bypass device for patients undergoing an elective anterior resection: a pilot study

Authors: A. Reshef, G. Ben-Arie, I. Pinsk

Published in: Techniques in Coloproctology | Issue 6/2019

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Abstract

Background

Currently, the only clinically valid method to prevent morbidity and mortality related to colorectal anastomotic leaks is by construction of a protective ileostomy. Intraluminal bypass might also be a possible way to proctect the anastomosis. The aim of the present study was to evaluate the CG-100 intraluminal bypass device for the reduction of anastomosis-related morbidity and stoma creation in cases of rectal resection.

Methods

A prospective study was conducted on patients having sphincter-preserving rectal resection who were treated with the CG-100 device at Soroka University Medical Center, Beer Sheva, Israel between May 2015 and February 2017. The device was implanted during surgery and removed after 10 ± 1 days. All patients underwent a radiologic leak test with water-soluble contrast prior to removal of the device. Patients were followed for 30 days. Information about adverse events, anastomotic leaks, device usability and tolerance were collected.

Results

Forty-seven patients participated in the study. Most patients were operated on due to cancer 44 (93.6%). Four (9%) patients received a primary protective stoma on top of the CG-100 device as part of the learning curve of the surgical team and none required a stoma after device removal. Five (9%) serious adverse events were reported, but only 2 (4%) were classified as related to the device. One was a transient enterocutaneous fistula after removal of the device. The second was an asymptomatic radiologic leak in 1 (2.1%) patient which was treated by keeping the device in place and antibiotic treatment for another 10 days without creation of diverting ileostomy.

Conclusions

CG-100 may provide a safe method for fecal diversion over a newly created anastomosis without the complications related to stoma creation and closure. A larger prospective randomized study in patients originally scheduled to receive diverting stoma is needed to confirm these findings.
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Metadata
Title
Protection of colorectal anastomosis with an intraluminal bypass device for patients undergoing an elective anterior resection: a pilot study
Authors
A. Reshef
G. Ben-Arie
I. Pinsk
Publication date
01-06-2019
Publisher
Springer International Publishing
Published in
Techniques in Coloproctology / Issue 6/2019
Print ISSN: 1123-6337
Electronic ISSN: 1128-045X
DOI
https://doi.org/10.1007/s10151-019-02015-9

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