Laparoscopic Versus Open Left Colonic Resection

NCT ID: NCT00894725

Last Updated: 2009-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 268 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-02-29
• Study Completion Date: 2008-12-31

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.

Conditions

Colon Cancer; Benign Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LPS

laparoscopic left colonic resection

Group Type: EXPERIMENTAL

laparoscopic left colonic resection

Intervention Type: PROCEDURE

laparoscopic colonic resection

Open

open left colonic resection

Group Type: ACTIVE_COMPARATOR

open left colonic resection

Intervention Type: PROCEDURE

conventional open colonic resection

Interventions

laparoscopic left colonic resection

laparoscopic colonic resection

Intervention Type: PROCEDURE

open left colonic resection

conventional open colonic resection

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università Vita-Salute San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

San Raffaele Vita-Salute University

Principal Investigators

Marco Braga, MD

Role: STUDY_DIRECTOR

San Raffaele Vita-Salute University

Locations

San Raffaele Hospital, Surgical Department

Milan, , Italy

Countries

Italy

References

Braga M, Frasson M, Zuliani W, Vignali A, Pecorelli N, Di Carlo V. Randomized clinical trial of laparoscopic versus open left colonic resection. Br J Surg. 2010 Aug;97(8):1180-6. doi: 10.1002/bjs.7094.

Reference Type: DERIVED

PMID: 20602506 (View on PubMed)

Other Identifiers

hmsxLPS09

Identifier Type: -

Identifier Source: org_study_id