NCT00894725

Laparoscopic Versus Open Left Colonic Resection

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 268 (actual)
• Sponsor: Università Vita-Salute San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colon Cancer
• Benign Disease

Interventions

Type	Name	Description
PROCEDURE	laparoscopic left colonic resection	laparoscopic colonic resection
PROCEDURE	open left colonic resection	conventional open colonic resection

Timeline

• Start date: 2000-02-01
• Primary completion: 2004-12-01
• Completion: 2008-12-01
• First posted: 2009-05-07
• Last updated: 2009-05-07

Locations

1 site across 1 country: Italy