Extracorporeal vs. Intracorporeal Ileocolic Stapled Anastomoses in Laparoscopic Right Colectomy: An Interim Analysis of a Randomized Clinical Trial.

Abstract

The role of intracorporeal anastomosis (IA) in right colectomy is still controversial. Primary endpoint of the present study is to evaluate the impact of IA versus extracorporeal anastomosis (EA) on recovery of bowel function and length of stay in right colon cancer patients. Adult patients with histologically proven cancer of the right colon were randomized to laparoscopic right colectomy with IA or EA anastomosis. Admitting a two-sided type I error level of 0.01 and an estimated power of 80%, 79 patients for each group were needed to test the primary endpoint. At the time of this interim analysis, 60 patients were randomized; 30 were assigned to the IA group and 30 to the EA group. The two groups were homogeneous with respect to demographics, American Surgical Association score, and tumor stage. In the IA group, a longer operating time (P = .04), an earlier recovery of bowel function (P = .048), and a lower incidence of postoperative ileus (P = .05) were observed. No differences were observed between the two groups with respect to length of stay (P = .70) and complication rate (P = .89). Anastomotic leak rate occurred in two patients in the IA group, while no leak occurred in EA. Intracorporeal anastomosis could be considered a valuable option in the hands of expert surgeons, with favorable effect on recovery of bowel function and postoperative ileus. Definitive answers on its safety and efficacy will be given once the present randomized controlled trial (RCT) will be complete.