Laparoscopic Versus Open Left Colonic Resection
NCT00894725 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 268
Last updated 2009-05-07
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.
Conditions
- Colon Cancer
- Benign Disease
Interventions
- PROCEDURE
-
laparoscopic left colonic resection
laparoscopic colonic resection
- PROCEDURE
-
open left colonic resection
conventional open colonic resection
Sponsors & Collaborators
-
Università Vita-Salute San Raffaele
lead OTHER
Principal Investigators
-
Marco Braga, MD · San Raffaele Vita-Salute University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2000-02-29
- Primary Completion
- 2004-12-31
- Completion
- 2008-12-31
Countries
- Italy
Study Locations
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