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Intraluminal flexible sheath for the protection of low anastomosis after anterior resection: results from a first-in-human trial on 15 patients.

Jeremie H Lefevre, Md, PhD1, Niels Komen, MD2, Antonio D’urso, MD3. 1Hopital Saint-Antoine, 2Antwerp University Hospital, 3CHRU Strasbourg

Introduction: Anastomotic leakage (AL) is one of the most feared complications after low anterior resection. Defunctioning ostomy is commonly used to protect patients from AL but has its own morbidity and mortality. This first-in-human study examines the safety and preliminary efficacy of Colovac, an anastomosis protection device, omitting the need for ostomies. The device consists of a flexible bypass sheath, placed in the lumen of the colonand anchored above the anastomosis using a vacuum-stent. 

Methods and procedures: In fifteen consecutive patients a Colovac device was placed immediately after anterior resection (AR) with low anastomosis. Patients were included in 3 different European centers, when a diverting ileostomy was deemed necessary. After 12 to 14 days, the anastomotic integrity was examined by CT-scan and by endoscopy. The device was then endoscopically pulled out. Data regarding demographics, surgical details, 30-day morbidity, patient satisfaction were collected prospectively. 

Results: All 15 patients (10 male, mean age 59) underwent laparoscopic or transanal AR for rectal cancer.  The Colovac device was placed after completion of the anastomosis, without construction of a diverting ostomy.  The device was uneventfully placed in all 15 patients with a mean duration of 7 min+/- 4SD, and was judged easy or very easy in 80% of the cases. Endoscopic removal was judged as easy or very easy in 87% of the cases. Patients did not report major discomfort. Minimal incontinence for loose stool was observed as long as the sheath was in situ. Absence of feces between the sheath and the colonic wall was observed in 100% of the cases.

Rate of AL and pelvic complications during or after the implantation period were 13% and 13%, 0% and 13%, respectively. At the end of follow-up, stoma could be avoided in 67% of the patients.

Conclusion: The Colovac device provides a safe, non-invasive alternative to ostomy by protecting the anastomosis during the first 14 days after surgery, potentially  omitting the need for ostomy and consequently improving the patients´ quality of life drastically. A study with a larger sample size is ongoing to further investigate the safety and performance of the Colovac device.


Presented at the SAGES 2017 Annual Meeting in Houston, TX.

Abstract ID: 95033

Program Number: S134

Presentation Session: Colorectal III

Presentation Type: Podium

49

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