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OpenTrials
Completed

NCT Number: NCT01040013

Gut Oxygenation and Laparoscopy

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.

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Key information

Conditions

Laparoscopy Cardiovascular Diseases Ischemia-Reperfusion Injury Laparotomy Oxygenation, Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

San Gerardo Hospital

Monza, 20052, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopy

Procedure

Laparoscopic Left-Colectomy

left colectomy by laparotomy

Procedure

PatientS will be operated by laparotomy

Primary outcomes

  1. Intestinal oxygenation

    Time frame: 7 DAYS

Secondary outcomes

  1. Ischemic reperfusion injury

    Time frame: 7 DAYS

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Registry information

Official study title

GUT OXYGENATION DURING AND AFTER LAPAROSCOPIC AND OPEN COLON RESECTION. A RANDOMIZAD CLINICAL TRIAL

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 25, 2009
Registry last updated
Dec 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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