Laparoscopic Versus Open Left Colonic Resection

Phase 3

Completed

• Conditions: Colon Cancer; Benign Disease

• Registration Number: NCT00894725
• Lead Sponsor: Università Vita-Salute San Raffaele

Brief 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.

Detailed 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 Timeline

• Study Start: 2000-02
• Primary Completion: 2004-12
• Study Completion: 2008-12
• Status Verified: 2009-05
• Study First Submitted: 2009-05-06
• Study First Submitted QC: 2009-05-06
• Last Update Submitted: 2009-05-06
• Study First Posted: 2009-05-07
• Last Update Posted: 2009-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 268

Inclusion Criteria

• age > 18 years
• suitability to elective surgery

Exclusion Criteria

• cancer infiltrating adjacent organs assessed by computed tomography
• cardiovascular dysfunction (New York Heart Association class > 3)
• respiratory dysfunction (arterial pO2 < 70 mmHg)
• hepatic dysfunction (Child-Pugh class C)
• ongoing infection
• plasma neutrophil level < 2.0x109/L

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
short-term morbidity rate	30 days

Secondary Outcome Measures

Name	Time	Method
long-term outcome	5 years

Trial Locations

Locations (1)

San Raffaele Hospital, Surgical Department; 🇮🇹 Milan, Italy