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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

  • 2019 SAGES Oral
  • Published:
Surgical Endoscopy Aims and scope Submit manuscript

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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Funding

This study has been funded by SafeHeal. SafeHeal is the manufacturer of the Colovac device. This study was presented as an oral communication at the 2019 SAGES Meeting in Baltimore, MD, USA.

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Authors and Affiliations

  1. Department of General, Digestive, and Endocrine Surgery, University Hospital of Strasbourg, Strasbourg, France

    Antonio D’Urso

  2. Department of Abdominal Surgery, University Hospital Antwerp, University of Antwerp, Edegem, Belgium

    Niels Komen

  3. Department of Digestive Surgery, Sorbonne Université, AP-HP, Hôpital Saint-Antoine, 75012, Paris, France

    Jérémie H. Lefevre

Authors
  1. Antonio D’Urso
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  2. Niels Komen
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  3. Jérémie H. Lefevre
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Correspondence to Jérémie H. Lefevre.

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Disclosures

Prof. J. H. Lefevre is a consultant for SafeHeal. Prof. J. H. Lefevre has received funding from SafeHeal to support congress registration and travel fees. Dr. A. D’Urso and Dr. N. Komen have no conflicts of interest to disclose.

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D’Urso, A., Komen, N. & Lefevre, J.H. Intraluminal flexible sheath for the protection of low anastomosis after anterior resection: results from a First-In-Human trial on 15 patients. Surg Endosc 34, 5107–5116 (2020). https://doi.org/10.1007/s00464-019-07279-8

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