Gut Oxygenation and Laparoscopy

This study has been completed.
Sponsor:
Information provided by:
University of Milano Bicocca
ClinicalTrials.gov Identifier:
NCT01040013
First received: December 24, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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 Intervention Phase
Laparoscopy
Laparotomy
Oxygenation,
Ischemia-Reperfusion Injury
Procedure: Laparoscopy
Procedure: left colectomy by laparotomy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: GUT OXYGENATION DURING AND AFTER LAPAROSCOPIC AND OPEN COLON RESECTION. A RANDOMIZAD CLINICAL TRIAL

Further study details as provided by University of Milano Bicocca:

Primary Outcome Measures:
  • Intestinal oxygenation [ Time Frame: 7 DAYS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ischemic reperfusion injury [ Time Frame: 7 DAYS ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2008
Study Completion Date: September 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01040013

Locations
Italy
San Gerardo Hospital
Monza, Italy, 20052
Sponsors and Collaborators
University of Milano Bicocca
Investigators
Principal Investigator: Luca Gianotti, MD, PhD Milano-Bicocca university
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: LUCA GIANOTTI, MD,SCD, MILNO-BICOCCA UNIVERSITY
ClinicalTrials.gov Identifier: NCT01040013     History of Changes
Other Study ID Numbers: oxylap-2009
Study First Received: December 24, 2009
Last Updated: December 24, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by University of Milano Bicocca:
LAPAROSCOPY,
LAPAROTOMY,
OXYGENATION,
ISCHEMIA-REPERFUSION INJURY

Additional relevant MeSH terms:
Ischemia
Reperfusion Injury
Wounds and Injuries
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications

ClinicalTrials.gov processed this record on April 16, 2014