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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014