Evaluation of the Proximate-ILS circular stapler. A prospective study.

In a prospective open study of the Proximate ILS circular stapler, the results of 125 intestinal anastomoses in 119 patients were reviewed. Intraoperative leakage was observed in five instances, after intraluminal povidone instillation, necessitating suture-line reinforcement. In three instances, incomplete tissue rings (donuts) were found. Temporary fecal diversion was used in seven of 84 patients with anastomoses made to the rectum or anal canal. Roentgenographic assessment of 79 of these anastomoses using Gastrografin demonstrated a leak in three (3.8%). There was one clinical leak (0.9%) in the series. Three patients died (2.5%), none from anastomotic complications. Transient anastomotic strictures were found in three of 82 operative survivors where the anastomosis was within range of the proctoscope. There were no instances of significant hemorrhage from the anastomosis. No patient required anastomotic revision, and of the 51 survivors of cancer surgery where proctoscopy could evaluate the anastomosis, there was no evidence of local recurrence in the period of follow up (mean 16.3 months). The authors conclude: that the Proximate ILS is a safe, reliable and effective instrument for construction of intestinal anastomoses.