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Endoluminal protection of colorectal anastomosis using a temporary non invasive bypass sheath: First in Human Clinical Data

Antonio D Urso1, Jeremie Lefevre, PhD2, Silvana Perretta, PhD1, Didier Mutter, Phd1, Cécile Dupont. 1IHU Strasbourg, 2hopital saint-Antoine

Objective: Anastomotic leak is one of the most feared complications after colorectal resection for low rectal cancer.  Diverting stoma is commonly performed in order to reduce the consequences of anastomotic failure, even if it could be avoided in patients presenting a primary healing of the anastomosis. An innovative system, ColovacTM, performing a temporary protection of the anastomosis was evaluated for the first time in human, in a multicentric study(2centers). It aims at avoiding the creation of a diverting stoma for the majority of patients who will recover without anastomotic complications.  ColovacTMconsists in a minimally invasive flexible bypass sheath, placed in the proximal colon to avoid any contact between stools and anastomosis obviating the need for stoma in patients with primary healing. The sheath is anchored using a stent and a vacuum system, sucking the colonic wall against the device. The study aims at investigating the safety,efficacy and tolerability of ColovacTMfor the protection of colorectal anastomosis in patients scheduled to receive a diverting stoma following rectal surgery.

Method: Patients operated on for low-rectal cancer were included in the study, after Ethical approval (National Study RegisterN°2016-A00978-43-A). Once the anastomosis was created, ColovacTMwas inserted endoluminally through the anal orifice using a dedicated introducer, the stent was delivered and expanded 20cm proximal to the anastomosis. The sheath and the vacuum tube were self-deployed distally through the anastomosis and the anal orifice. The vacuum tube was connected to a suction drain, providing constant aspiration during the implantation period in order to avoid migration of the device. No diverting stoma was created in these patients at the time of surgery. 

Results: ColovacTMwas inserted in five patients with coloanal(3)or low colorectal(2) anastomosis. Implantation ColovacTMwas technically successful in all cases, with immediate stent deployment and effective vacuum. No complications related to the ColovacTMdevice were observed for four out of five patients. For one patient, obstruction of the vacuum tube by impacted stools led to a premature retrieval of the device after six days. Overall tolerance was good. Minimal incontinence was observed. One patient reported perianal discomfort caused by liquid stools. Retrieval of the ColovacTM14-days after implantation was successfully achieved in all 4 cases, without complications. Endoscopic assessment performed at retrieval confirmed the absence of feces below the anchoring site, and no severe mucosal damage at the anchoring site. Two patients underwent a loop ileostomy for incomplete anastomotic healing after retrieval of the ColovacTM.

Conclusion: This preliminary experience demonstrates the feasibility and tolerability of the ColovacTM as a minimally invasive protection of lower anastomosis. It avoided a diverting stoma for the majority of patients (3patients out of 5) who recovered without anastomotic complications and for the two others, protected the anastomosis from the deleterious consequences of anastomotic failure.  It appears as a promising device to avoid a loop ileostomy in patients with primary healing.


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

Abstract ID: 91180

Program Number: ETP994

Presentation Session: Emerging Technology iPoster Session (Non CME)

Presentation Type: Poster

Post Views: 12

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