Status:
COMPLETED
Laparoscopic Versus Open Left Colonic Resection
Lead Sponsor:
Università Vita-Salute San Raffaele
Conditions:
Colon Cancer
Benign Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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. ...
Eligibility Criteria
Inclusion
- age \> 18 years
- suitability to elective surgery
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT00894725
Start Date
February 1 2000
End Date
December 1 2008
Last Update
May 7 2009
Active Locations (1)
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1
San Raffaele Hospital, Surgical Department
Milan, Italy, 20132