Gut Oxygenation and Laparoscopy
GUT OXYGENATION DURING AND AFTER LAPAROSCOPIC AND OPEN COLON RESECTION. A RANDOMIZAD CLINICAL TRIAL
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 24, 2009
CompletedFirst Posted
Study publicly available on registry
December 25, 2009
CompletedDecember 25, 2009
November 1, 2009
1 year
December 24, 2009
December 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intestinal oxygenation
7 DAYS
Secondary Outcomes (1)
Ischemic reperfusion injury
7 DAYS
Study Arms (2)
Laparoscopy
EXPERIMENTALLaparoscopic Left-Sided Colectomy
laparotomy
ACTIVE COMPARATORLaparotomic Left-Sided Colectomy
Interventions
Eligibility Criteria
You may qualify if:
- Proven Cleft Colon Cancer, Signed Informed Consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Gerardo Hospital
Monza, 20052, Italy
Related Publications (2)
Moore K, Roberts LJ 2nd. Measurement of lipid peroxidation. Free Radic Res. 1998 Jun;28(6):659-71. doi: 10.3109/10715769809065821.
PMID: 9736317BACKGROUNDGianotti 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.
PMID: 21136109DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luca Gianotti, MD, PhD
Milano-Bicocca university
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 24, 2009
First Posted
December 25, 2009
Study Start
March 1, 2008
Primary Completion
March 1, 2009
Study Completion
September 1, 2009
Last Updated
December 25, 2009
Record last verified: 2009-11