Intraluminal flexible sheath for the protection of low anastomosis after anterior resection: results from a First-In-Hum
- PDF / 617,758 Bytes
- 10 Pages / 595.276 x 790.866 pts Page_size
- 77 Downloads / 192 Views
and Other Interventional Techniques
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 Antonio D’Urso1 · Niels Komen2 · Jérémie H. Lefevre3 Received: 9 April 2019 / Accepted: 23 November 2019 © Springer Science+Business Media, LLC, part of Springer Nature 2019
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. Keywords Rectal cancer · Stoma · Bypass sheath · Stent · Anastomotic leakage Colorectal cancer represents the third most common cancer and the second most common cause for cancer mortality worldwide, with 1.8 million diagnoses and 881,000 expected deaths in 2018 [1]. Despite improvement in the perioperative management of anterior resection for rectal cancer, the * Jérémie H. Lefevre [email protected] 1
Department of General, Digestive, and Endocrine Surgery, University Hospital of Strasbourg, Strasbourg, France
2
Department of Abdominal Surgery, University Hospital Antwerp, University of Antwerp, Edegem, Belgium
3
Department of Digestive Surgery, Sorbonne Université, AP‑HP, Hôpital Saint‑Antoine, 75012 Paris, France
rate of anastomotic leakages is st
Data Loading...
