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J Laparoendosc Adv Surg Tech A · May 2016
Randomized Controlled TrialExtracorporeal vs. Intracorporeal Ileocolic Stapled Anastomoses in Laparoscopic Right Colectomy: An Interim Analysis of a Randomized Clinical Trial.
- Andrea Vignali, Massimiliano Bissolati, Paola De Nardi, Saverio Di Palo, and Carlo Staudacher.
- Department of Surgery, IRCCS San Raffaele, University Vita e Salute , Milan, Italy .
- J Laparoendosc Adv Surg Tech A. 2016 May 1; 26 (5): 343-8.
AimThe 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.Materials And MethodsAdult 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.ResultsAt 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.ConclusionsIntracorporeal 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.
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