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Gut Oxygenation and Laparoscopy

Primary Purpose

Laparoscopy, Laparotomy, Oxygenation,

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Laparoscopy
left colectomy by laparotomy
Sponsored by
University of Milano Bicocca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopy focused on measuring LAPAROSCOPY,, LAPAROTOMY,, OXYGENATION,, ISCHEMIA-REPERFUSION INJURY

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • San Gerardo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopy

laparotomy

Arm Description

Laparoscopic Left-Sided Colectomy

Laparotomic Left-Sided Colectomy

Outcomes

Primary Outcome Measures

Intestinal oxygenation

Secondary Outcome Measures

Ischemic reperfusion injury

Full Information

First Posted
December 24, 2009
Last Updated
December 24, 2009
Sponsor
University of Milano Bicocca
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1. Study Identification

Unique Protocol Identification Number
NCT01040013
Brief Title
Gut Oxygenation and Laparoscopy
Official Title
GUT OXYGENATION DURING AND AFTER LAPAROSCOPIC AND OPEN COLON RESECTION. A RANDOMIZAD CLINICAL TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Milano Bicocca

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopy, Laparotomy, Oxygenation,, Ischemia-Reperfusion Injury
Keywords
LAPAROSCOPY,, LAPAROTOMY,, OXYGENATION,, ISCHEMIA-REPERFUSION INJURY

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopy
Arm Type
Experimental
Arm Description
Laparoscopic Left-Sided Colectomy
Arm Title
laparotomy
Arm Type
Active Comparator
Arm Description
Laparotomic Left-Sided Colectomy
Intervention Type
Procedure
Intervention Name(s)
Laparoscopy
Intervention Description
Laparoscopic Left-Colectomy
Intervention Type
Procedure
Intervention Name(s)
left colectomy by laparotomy
Intervention Description
PatientS will be operated by laparotomy
Primary Outcome Measure Information:
Title
Intestinal oxygenation
Time Frame
7 DAYS
Secondary Outcome Measure Information:
Title
Ischemic reperfusion injury
Time Frame
7 DAYS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Gianotti, MD, PhD
Organizational Affiliation
Milano-Bicocca university
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Gerardo Hospital
City
Monza
ZIP/Postal Code
20052
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
9736317
Citation
Moore K, Roberts LJ 2nd. Measurement of lipid peroxidation. Free Radic Res. 1998 Jun;28(6):659-71. doi: 10.3109/10715769809065821.
Results Reference
background
PubMed Identifier
21136109
Citation
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.
Results Reference
derived

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Gut Oxygenation and Laparoscopy

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