Laparoscopic Versus Open Left Colonic Resection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00894725|
Recruitment Status : Completed
First Posted : May 7, 2009
Last Update Posted : May 7, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer Benign Disease||Procedure: laparoscopic left colonic resection Procedure: open left colonic resection||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||268 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Laparoscopic vs. Open Left Colonic Resection: a Randomized Monocentric Trial|
|Study Start Date :||February 2000|
|Actual Primary Completion Date :||December 2004|
|Actual Study Completion Date :||December 2008|
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
- short-term morbidity rate [ Time Frame: 30 days ]
- long-term outcome [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00894725
|San Raffaele Hospital, Surgical Department|
|Milan, Italy, 20132|
|Study Director:||Marco Braga, MD||San Raffaele Vita-Salute University|