Laparoscopic Versus Open Left Colonic Resection

Colon Cancer Clinical Trial

Official title:

Laparoscopic vs. Open Left Colonic Resection: a Randomized Monocentric Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00894725
• Other study ID #: hmsxLPS09
• Status: Completed
• Phase: Phase 3
• First received: May 6, 2009
• Last updated: May 6, 2009
• Start date: February 2000
• Est. completion date: December 2008

Study information

• Verified date: May 2009
• Source: Università Vita-Salute San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: December 2008
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Disease
• Colon Cancer

Intervention

Procedure:
• laparoscopic left colonic resection
laparoscopic colonic resection
• open left colonic resection
conventional open colonic resection

Locations

Country	Name	City	State
Italy	San Raffaele Hospital, Surgical Department	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Università Vita-Salute San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	short-term morbidity rate		30 days	No
Secondary	long-term outcome		5 years	No