- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01040013
Gut Oxygenation and Laparoscopy
December 24, 2009 updated by: University of Milano Bicocca
GUT OXYGENATION DURING AND AFTER LAPAROSCOPIC AND OPEN COLON RESECTION. A RANDOMIZAD CLINICAL TRIAL
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Monza, Italy, 20052
- San Gerardo Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Laparoscopy
Laparoscopic Left-Sided Colectomy
|
Laparoscopic Left-Colectomy
|
Active Comparator: laparotomy
Laparotomic Left-Sided Colectomy
|
PatientS will be operated by laparotomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intestinal oxygenation
Time Frame: 7 DAYS
|
7 DAYS
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ischemic reperfusion injury
Time Frame: 7 DAYS
|
7 DAYS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Luca Gianotti, MD, PhD, Milano-Bicocca University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Moore K, Roberts LJ 2nd. Measurement of lipid peroxidation. Free Radic Res. 1998 Jun;28(6):659-71. doi: 10.3109/10715769809065821.
- Gianotti L, Nespoli L, Rocchetti S, Vignali A, Nespoli A, Braga M. Gut oxygenation and oxidative damage during and after laparoscopic and open left-sided colon resection: a prospective, randomized, controlled clinical trial. Surg Endosc. 2011 Jun;25(6):1835-43. doi: 10.1007/s00464-010-1475-2. Epub 2010 Dec 7.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
December 24, 2009
First Submitted That Met QC Criteria
December 24, 2009
First Posted (Estimate)
December 25, 2009
Study Record Updates
Last Update Posted (Estimate)
December 25, 2009
Last Update Submitted That Met QC Criteria
December 24, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- oxylap-2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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