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


Phase 2
18 Years
80 Years
Not Enrolling
Both
Laparoscopy, Laparotomy, Oxygenation,, Ischemia-Reperfusion Injury

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Intestinal oxygenation

Outcome Time Frame:

7 DAYS

Safety Issue:

No

Principal Investigator

Luca Gianotti, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Milano-Bicocca university

Authority:

Italy: Ethics Committee

Study ID:

oxylap-2009

NCT ID:

NCT01040013

Start Date:

March 2008

Completion Date:

September 2009

Related Keywords:

  • Laparoscopy
  • Laparotomy
  • Oxygenation,
  • Ischemia-Reperfusion Injury
  • LAPAROSCOPY,
  • LAPAROTOMY,
  • OXYGENATION,
  • ISCHEMIA-REPERFUSION INJURY
  • Ischemia
  • Reperfusion Injury

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