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Gut Oxygenation and Laparoscopy

NCT ID: NCT01040013

Last Updated: 2009-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Laparoscopy Laparotomy Oxygenation, Ischemia-Reperfusion Injury

Keywords

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LAPAROSCOPY, LAPAROTOMY, OXYGENATION, ISCHEMIA-REPERFUSION INJURY

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparoscopy

Laparoscopic Left-Sided Colectomy

Group Type EXPERIMENTAL

Laparoscopy

Intervention Type PROCEDURE

Laparoscopic Left-Colectomy

laparotomy

Laparotomic Left-Sided Colectomy

Group Type ACTIVE_COMPARATOR

left colectomy by laparotomy

Intervention Type PROCEDURE

PatientS will be operated by laparotomy

Interventions

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Laparoscopy

Laparoscopic Left-Colectomy

Intervention Type PROCEDURE

left colectomy by laparotomy

PatientS will be operated by laparotomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Milano Bicocca

OTHER

Sponsor Role lead

Responsible Party

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MILNO-BICOCCA UNIVERSITY

Principal Investigators

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Luca Gianotti, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Milano-Bicocca university

Locations

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San Gerardo Hospital

Monza, , Italy

Site Status

Countries

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Italy

References

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Moore K, Roberts LJ 2nd. Measurement of lipid peroxidation. Free Radic Res. 1998 Jun;28(6):659-71. doi: 10.3109/10715769809065821.

Reference Type BACKGROUND
PMID: 9736317 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21136109 (View on PubMed)

Other Identifiers

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oxylap-2009

Identifier Type: -

Identifier Source: org_study_id