- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00894725
Laparoscopic Versus Open Left Colonic Resection
Laparoscopic vs. Open Left Colonic Resection: a Randomized Monocentric Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Milan, Italy, 20132
- San Raffaele Hospital, Surgical Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LPS
laparoscopic left colonic resection
|
laparoscopic colonic resection
|
Active Comparator: Open
open left colonic resection
|
conventional open colonic resection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
short-term morbidity rate
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
long-term outcome
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Investigators
- Study Director: Marco Braga, MD, San Raffaele Vita-Salute University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- hmsxLPS09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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