Laparoscopic Versus Open Left Colonic Resection
Primary Purpose
Colon Cancer, Benign Disease
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
laparoscopic left colonic resection
open left colonic resection
Sponsored by
About this trial
This is an interventional treatment trial for Colon Cancer focused on measuring left colon cancer
Eligibility Criteria
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
Sites / Locations
- San Raffaele Hospital, Surgical Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LPS
Open
Arm Description
laparoscopic left colonic resection
open left colonic resection
Outcomes
Primary Outcome Measures
short-term morbidity rate
Secondary Outcome Measures
long-term outcome
Full Information
NCT ID
NCT00894725
First Posted
May 6, 2009
Last Updated
May 6, 2009
Sponsor
Università Vita-Salute San Raffaele
1. Study Identification
Unique Protocol Identification Number
NCT00894725
Brief Title
Laparoscopic Versus Open Left Colonic Resection
Official Title
Laparoscopic vs. Open Left Colonic Resection: a Randomized Monocentric Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
February 2000 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Università Vita-Salute San Raffaele
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Benign Disease
Keywords
left colon cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
268 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LPS
Arm Type
Experimental
Arm Description
laparoscopic left colonic resection
Arm Title
Open
Arm Type
Active Comparator
Arm Description
open left colonic resection
Intervention Type
Procedure
Intervention Name(s)
laparoscopic left colonic resection
Intervention Description
laparoscopic colonic resection
Intervention Type
Procedure
Intervention Name(s)
open left colonic resection
Intervention Description
conventional open colonic resection
Primary Outcome Measure Information:
Title
short-term morbidity rate
Time Frame
30 days
Secondary Outcome Measure Information:
Title
long-term outcome
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Braga, MD
Organizational Affiliation
San Raffaele Vita-Salute University
Official's Role
Study Director
Facility Information:
Facility Name
San Raffaele Hospital, Surgical Department
City
Milan
ZIP/Postal Code
20132
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
20602506
Citation
Braga M, Frasson M, Zuliani W, Vignali A, Pecorelli N, Di Carlo V. Randomized clinical trial of laparoscopic versus open left colonic resection. Br J Surg. 2010 Aug;97(8):1180-6. doi: 10.1002/bjs.7094.
Results Reference
derived
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Laparoscopic Versus Open Left Colonic Resection
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