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Gut Oxygenation and Laparoscopy

U

University of Milano Bicocca

Status and phase

Completed
Phase 2

Conditions

Oxygenation,
Laparotomy
Laparoscopy
Ischemia-Reperfusion Injury

Treatments

Procedure: left colectomy by laparotomy
Procedure: Laparoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT01040013
oxylap-2009

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Laparoscopy
Experimental group
Description:
Laparoscopic Left-Sided Colectomy
Treatment:
Procedure: Laparoscopy
laparotomy
Active Comparator group
Description:
Laparotomic Left-Sided Colectomy
Treatment:
Procedure: left colectomy by laparotomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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