Spots Global Cancer Trial Database for Laparoscopic Versus Open Left Colonic Resection

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Trial Identification

Brief Title: Laparoscopic Versus Open Left Colonic Resection

Official Title: Laparoscopic vs. Open Left Colonic Resection: a Randomized Monocentric Trial

Study ID: NCT00894725

Conditions

Colon Cancer

Benign Disease

Interventions

laparoscopic left colonic resection

open left colonic resection

Study Description

Brief Summary: The main goal of this study is to clarify if laparoscopy (LPS) could become the standard approach in patients undergoing left colonic resection. 268 patient candidates to left colonic resection were randomly assigned to LPS (n=134) or open (n=134) approach. Postoperative care protocol was the same in both groups. Trained members of the surgical staff who were not involved in the study registered 30-day postoperative morbidity. Cost-benefit analysis was based on hospital costs. Long-term morbidity, quality of life, and 5-year survival have also been evaluated.

Detailed Description: The study design was explained to the potential participants who were asked to sign a written informed consent before randomization. Eligible patients were randomly allocated to LPS or open surgery. Randomization list was computer generated. Assignments were made by means of sealed sequenced masked envelopes which were opened, before the induction of anesthesia, by a nurse unaware of the trial design.