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