Gut Oxygenation and Laparoscopy

• Sponsor: University of Milano Bicocca (Other)
• Overall Status: Completed
• CT.gov ID: NCT01040013
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 18
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Laparoscopy; Laparotomy; Oxygenation,; Ischemia-Reperfusion Injury	Procedure: Laparoscopy; Procedure: left colectomy by laparotomy	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: GUT OXYGENATION DURING AND AFTER LAPAROSCOPIC AND OPEN COLON RESECTION. A RANDOMIZAD CLINICAL TRIAL
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laparoscopy Laparoscopic Left-Sided Colectomy	Procedure: Laparoscopy; Laparoscopic Left-Colectomy
Active Comparator: laparotomy Laparotomic Left-Sided Colectomy	Procedure: left colectomy by laparotomy; PatientS will be operated by laparotomy

Outcome Measures

Primary Outcome Measures

1. Intestinal oxygenation [7 DAYS]

Secondary Outcome Measures

1. Ischemic reperfusion injury [7 DAYS]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Gerardo Hospital	Monza		Italy	20052

Sponsors and Collaborators

• University of Milano Bicocca

Investigators

• Principal Investigator: Luca Gianotti, MD, PhD, Milano-Bicocca university

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• ClinicalTrials.gov Identifier: NCT01040013
• Other Study ID Numbers: oxylap-2009
• First Posted: Dec 25, 2009
• Last Update Posted: Dec 25, 2009
• Last Verified: Nov 1, 2009

• Keywords provided by , ,: LAPAROSCOPY,; LAPAROTOMY,; OXYGENATION,; ISCHEMIA-REPERFUSION INJURY
• Additional relevant MeSH terms: Reperfusion Injury; Ischemia

Study Results

No Results Posted as of Dec 25, 2009