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

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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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Authors and Affiliations

  1. Colorectal Unit, Department of Surgery, Soroka University Medical Center, Beersheba, Israel

    A. Reshef & I. Pinsk

  2. Diagnostic Imaging Department, Soroka University Medical Center, Beersheba, Israel

    G. Ben-Arie

Authors
  1. A. Reshef
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  2. G. Ben-Arie
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  3. I. Pinsk
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Contributions

All authors were involved in study design, patient recruitment, data collection and writing or reviewing the manuscript.

Corresponding author

Correspondence to A. Reshef.

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Conflict of interest and funding

Study was sponsored by Colospan Ltd.; none of the authors have any direct involvement with the company. Data collection was done by the company, but the analysis was done independent of any company involvement.

Ethical approval

All procedures performed in the study involving human participants were in accordance with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Reshef, A., Ben-Arie, G. & Pinsk, I. Protection of colorectal anastomosis with an intraluminal bypass device for patients undergoing an elective anterior resection: a pilot study. Tech Coloproctol 23, 565–571 (2019). https://doi.org/10.1007/s10151-019-02015-9

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  • DOI: https://doi.org/10.1007/s10151-019-02015-9

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