Laparoscopic Versus Open Left Colonic Resection

NCT00894725 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2009-05-07

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00894725 on ClinicalTrials.gov