Gut Oxygenation and Laparoscopy

Phase 2

Completed

• Conditions: Laparoscopy; Laparotomy; Oxygenation,; Ischemia-Reperfusion Injury
• Interventions: Procedure: Laparoscopy; Procedure: left colectomy by laparotomy

• Registration Number: NCT01040013
• Lead Sponsor: University of Milano Bicocca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-03
• Study Completion: 2009-09
• Status Verified: 2009-11
• Study First Submitted: 2009-12-24
• Study First Submitted QC: 2009-12-24
• Last Update Submitted: 2009-12-24
• Study First Posted: 2009-12-25
• Last Update Posted: 2009-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopy	Laparoscopy	Laparoscopic Left-Sided Colectomy
laparotomy	left colectomy by laparotomy	Laparotomic Left-Sided Colectomy

Primary Outcome Measures

Name	Time	Method
Intestinal oxygenation	7 DAYS

Secondary Outcome Measures

Name	Time	Method
Ischemic reperfusion injury	7 DAYS

Trial Locations

Locations (1)

San Gerardo Hospital; 🇮🇹 Monza, Italy