Circular 'superelastic' compression anastomosis: from the animal lab to clinical practice.

The recent development of a compression device using shape memory Nitinol technology to create an end-to-end anastomosis has renewed the interest in sutureless anastomotic techniques. A phase II, prospective open label clinical trial was started in May 2007 to evaluate the feasibility and safety of this new anastomotic device. Fourty patients who need left colectomy or high anterior resection for either diverticular disease or adenocarcinoma will be recruited in two academic hospitals (Uppsala,Sweden and Leuven, Belgium). Clinical leakage is the primary endpoint. Only preliminary results are available to date as the recruitment is ongoing. The median age of the first ten patients is 57.5 years (44-72). No anastomotic leakage occurred. The median hospital stay was 4.0 days. Only three patients noticed the passage of the ring through the anal canal. By three weeks no ring was sustained in the gastrointestinal tract as was objectified by plain X-ray. First clinical use of this new anastomotic device seems promising. Final results for the total phase II trial are awaited. A prospective randomized trial to compare the efficacy of the EndoCar 28 with conventional stapling should be the next step.

RCT Entities:   Population Interventions Outcomes