Laparoscopic Versus Open Left Colonic Resection
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.
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Colon Cancer
Intervention
laparoscopic left colonic resection, open left colonic resection
Location
San Raffaele Hospital, Surgical Department
Milan
Italy
20132
Status
Completed
Source
Università Vita-Salute San Raffaele
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00894725
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Diverticulitis, Colonic
Inflammation of the COLONIC DIVERTICULA, generally with abscess formation and subsequent perforation.
Colonic Diseases, Functional
Chronic or recurrent colonic disorders without an identifiable structural or biochemical explanation. The widely recognized IRRITABLE BOWEL SYNDROME falls into this category.
Diverticulosis, Colonic
A pathological condition characterized by the presence of a number of COLONIC DIVERTICULA in the COLON. Its pathogenesis is multifactorial, including colon aging, motor dysfunction, increases in intraluminal pressure, and lack of dietary fibers.
Colon, Transverse
The segment of LARGE INTESTINE between ASCENDING COLON and DESCENDING COLON. It passes from the RIGHT COLIC FLEXURE across the ABDOMEN, then turns sharply at the left colonic flexure into the descending colon.
Heart Bypass, Left
Diversion of the flow of blood from the pulmonary veins directly to the aorta, avoiding the left atrium and the left ventricle (Dorland, 27th ed). This is a temporary procedure usually performed to assist other surgical procedures.
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