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Surgical Endoscopy

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01-11-2020 | Rectal Cancer | 2019 SAGES Oral

Intraluminal flexible sheath for the protection of low anastomosis after anterior resection: results from a First-In-Human trial on 15 patients

Authors: Antonio D’Urso, Niels Komen, Jérémie H. Lefevre

Published in: Surgical Endoscopy | Issue 11/2020

Abstract

Background

Defunctioning ostomy is commonly used to protect patients from anastomotic leakage complications after low anterior resection, but is fraught with its own deleterious effects. This first-in-human study examines the safety and preliminary efficacy of Colovac, an anastomosis protection device. The Colovac consists of a flexible bypass sheath, placed in the lumen of colon and anchored above the anastomosis using a vacuum stent.

Methods

15 patients underwent anterior resection (AR) with anastomosis protection by Colovac at 3 European centers. After 14 days, the anastomosis integrity was examined by CT scan and endoscopy. The device was then endoscopically removed. Data regarding demographics, surgical details, 30 day post-operative complications, and patient satisfaction were collected prospectively.

Results

15 patients (10 male) underwent laparoscopic AR with Colovac placement. Preoperative neoadjuvant therapy was administered to 54% of patients. Device placement was uneventful in all patients with a median duration of 7 min and placement was judged as easy or very easy in 93% of the cases. Patients did not report major discomfort during the 14 days. Endoscopic removal (10 min) was judged as easy or very easy in 87% of the cases. Absence of feces below the Colovac anchoring site was observed in 100% of the cases. 4 anastomotic leakages were observed (including 3 device migrations). Overall 5 patients (33%) required a planned stoma creation. At 3 months, 1 had already been closed.

Conclusion

Colovac provides a minimally invasive protection of the anastomosis during the healing process by avoiding the need for a diverting ostomy for two-thirds of patients who will not experience anastomotic complications and allowing safe conversion to the standard of care for patients requiring extended anastomotic protection. A larger study is ongoing to confirm these results.

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Title: Intraluminal flexible sheath for the protection of low anastomosis after anterior resection: results from a First-In-Human trial on 15 patients
Authors: Antonio D’Urso
Niels Komen
Jérémie H. Lefevre
Publication date: 01-11-2020
Publisher: Springer US
Keywords: Rectal Cancer
Rectal Cancer
Enterostomy
Enterostomy
Published in: Surgical Endoscopy / Issue 11/2020
Print ISSN: 0930-2794
Electronic ISSN: 1432-2218
DOI: https://doi.org/10.1007/s00464-019-07279-8

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Intraluminal flexible sheath for the protection of low anastomosis after anterior resection: results from a First-In-Human trial on 15 patients

Abstract

Background

Methods

Results

Conclusion

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Background

Methods

Results

Conclusion

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