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NCT01040013 Clinical Trial

Gut Oxygenation and Laparoscopy

Laparoscopy Clinical Trial

Official title:
GUT OXYGENATION DURING AND AFTER LAPAROSCOPIC AND OPEN COLON RESECTION. A RANDOMIZAD CLINICAL TRIAL

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01040013
Other study ID # oxylap-2009
Secondary ID
Status Completed
Phase Phase 2
First received December 24, 2009
Last updated December 24, 2009
Start date March 2008
Est. completion date September 2009

Study information
Verified date November 2009
Source University of Milano Bicocca
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Laparoscopy
Laparoscopic Left-Colectomy
• left colectomy by laparotomy
PatientS will be operated by laparotomy

Locations
Country Name City State
Italy San Gerardo Hospital Monza

Sponsors (1)
Lead Sponsor Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Moore K, Roberts LJ 2nd. Measurement of lipid peroxidation. Free Radic Res. 1998 Jun;28(6):659-71. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Intestinal oxygenation 7 DAYS No
Secondary Ischemic reperfusion injury 7 DAYS No
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