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Title
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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
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Author
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Abstract
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| 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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Language
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English
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Source (journal)
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Surgical endoscopy: ultrasound and interventional techniques. - New York
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Publication
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New york
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Springer
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2020
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ISSN
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0930-2794
[print]
1432-2218
[online]
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DOI
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10.1007/S00464-019-07279-8
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Volume/pages
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34
:11
(2020)
, p. 5107-5116
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ISI
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000500637200001
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Pubmed ID
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31802217
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Full text (Publisher's DOI)
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Full text (publisher's version - intranet only)
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