Laparoscopic Versus Open Left Colonic Resection
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.
|Colon Cancer Benign Disease||Procedure: laparoscopic left colonic resection Procedure: open left colonic resection||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Laparoscopic vs. Open Left Colonic Resection: a Randomized Monocentric Trial|
- short-term morbidity rate [ Time Frame: 30 days ]
- long-term outcome [ Time Frame: 5 years ]
|Study Start Date:||February 2000|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2004 (Final data collection date for primary outcome measure)|
laparoscopic left colonic resection
Procedure: laparoscopic left colonic resection
laparoscopic colonic resection
Active Comparator: Open
open left colonic resection
Procedure: open left colonic resection
conventional open colonic resection
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00894725
|San Raffaele Hospital, Surgical Department|
|Milan, Italy, 20132|
|Study Director:||Marco Braga, MD||San Raffaele Vita-Salute University|