Gut Oxygenation and Laparoscopy

University of Milano Bicocca

Status and phase: Completed; Phase 2

Conditions: Oxygenation,; Laparotomy; Laparoscopy; Ischemia-Reperfusion Injury

Treatments: Procedure: left colectomy by laparotomy; Procedure: Laparoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01040013

oxylap-2009

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Laparoscopy

Experimental group

Description:

Laparoscopic Left-Sided Colectomy

Treatment:

Procedure: Laparoscopy

laparotomy

Active Comparator group

Description:

Laparotomic Left-Sided Colectomy

Treatment:

Procedure: left colectomy by laparotomy