Colon Cancer Clinical Trial
Official title:
Laparoscopic vs. Open Left Colonic Resection: a Randomized Monocentric Trial
Verified date | May 2009 |
Source | Università Vita-Salute San Raffaele |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 268 |
Est. completion date | December 2008 |
Est. primary completion date | December 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | San Raffaele Hospital, Surgical Department | Milan |
Lead Sponsor | Collaborator |
---|---|
Università Vita-Salute San Raffaele |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | short-term morbidity rate | 30 days | No | |
Secondary | long-term outcome | 5 years | No |
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