Laparoscopic Versus Open Left Colonic Resection

• Sponsor: Università Vita-Salute San Raffaele (Other)
• Overall Status: Completed
• CT.gov ID: NCT00894725
• Collaborator: (none)
• Enrollment: 268
• Location: 1
• Arms: 2
• Duration (Months): 106
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer; Benign Disease	Procedure: laparoscopic left colonic resection; Procedure: open left colonic resection	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 268 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Laparoscopic vs. Open Left Colonic Resection: a Randomized Monocentric Trial
• Study Start Date: Feb 1, 2000
• Actual Primary Completion Date: Dec 1, 2004
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LPS laparoscopic left colonic resection	Procedure: laparoscopic left colonic resection; laparoscopic colonic resection
Active Comparator: Open open left colonic resection	Procedure: open left colonic resection; conventional open colonic resection

Outcome Measures

Primary Outcome Measures

1. short-term morbidity rate [30 days]

Secondary Outcome Measures

1. long-term outcome [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Raffaele Hospital, Surgical Department	Milan		Italy	20132

Sponsors and Collaborators

• Università Vita-Salute San Raffaele

Investigators

• Study Director: Marco Braga, MD, San Raffaele Vita-Salute University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00894725
• Other Study ID Numbers: hmsxLPS09
• First Posted: May 7, 2009
• Last Update Posted: May 7, 2009
• Last Verified: May 1, 2009

• Keywords provided by , ,: left colon cancer
• Additional relevant MeSH terms: Colonic Neoplasms

Study Results

No Results Posted as of May 7, 2009