Laparoscopy Clinical Trial
Official title:
GUT OXYGENATION DURING AND AFTER LAPAROSCOPIC AND OPEN COLON RESECTION. A RANDOMIZAD CLINICAL TRIAL
Verified date | November 2009 |
Source | University of Milano Bicocca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
Patients with left-colon cancer will be randomized to laparoscopic or laparotomic operation. during surgery and for 6 days after operation, intestinal oxygen tension and ischemia-reperfusion injury markers will be evaluated to understand if pneumoperitoneum is associated with reduced splanchnic blood flow and ischemia-reperfusion injury.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Proven Cleft Colon Cancer, Signed Informed Consent Exclusion Criteria: - Emergency surgery, - Cancer infiltrating adjacent organ (at CT scan), - Severe cardiovascular (New York Heart Association class > 3 ), - Respiratory (arterial PO2 < 70 mmHg), - Renal (plasma creatinine > 3 MG/dL) or hepatic (Child C) dysfunction |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | San Gerardo Hospital | Monza |
Lead Sponsor | Collaborator |
---|---|
University of Milano Bicocca |
Italy,
Moore K, Roberts LJ 2nd. Measurement of lipid peroxidation. Free Radic Res. 1998 Jun;28(6):659-71. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intestinal oxygenation | 7 DAYS | No | |
Secondary | Ischemic reperfusion injury | 7 DAYS | No |
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