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Clinical Trials/NCT00894725
NCT00894725CompletedPhase 3

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

Università Vita-Salute San Raffaele2 sites in 1 country268 target enrollmentStarted: February 2000Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
268
Locations
2
Primary Endpoint
short-term morbidity rate

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

short-term morbidity rate

Time Frame: 30 days

Secondary Outcomes

  • long-term outcome(5 years)

Investigators

Sponsor Class
Other

Study Sites (2)

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