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Nitrous Oxide Does Not Increase the Risk of Cancer Recurrence After Colorectal Surgery: A Randomized, Blinded Study


Phase 3
18 Years
80 Years
Not Enrolling
Both
Colorectal Cancer

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Trial Information

Nitrous Oxide Does Not Increase the Risk of Cancer Recurrence After Colorectal Surgery: A Randomized, Blinded Study


We conducted a 4- to 8-year follow-up of 204 patients with colorectal cancer who were
randomly assigned to 65% nitrous oxide (n=97) or nitrogen (n=107), balanced with isoflurane
and remifentanil. The primary outcome was the time to cancer recurrence. Our primary
analysis was a multivariable Cox-proportional-hazards regression model that included
relevant baseline variables. In addition to treatment group, the model considered patient
age, tumor grade, dissemination, adjacent organ invasion, vessel invasion, and the number of
nodes involved. The study had 80% power to detect a 56% or greater reduction in recurrence
rates (i.e., hazard ratio of 0.44 or less) at the 0.05 significance level.


Inclusion Criteria:



- Subjects age 18-18

- ASA status 1-3

- Informed consent

Exclusion Criteria:

- Acute bowel obstruction

- Minor colon surgery

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

To determine if the risk of colorectal cancer recurrence was similar in patients who were randomly assigned to 65% nitrous oxide or nitrogen during colorectal surgery.

Outcome Time Frame:

270 days post surrgery

Safety Issue:

No

Principal Investigator

Edith Fleischmann, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of Vienna

Authority:

Austria: Ethikkommission

Study ID:

efno1008

NCT ID:

NCT00781352

Start Date:

November 1998

Completion Date:

March 2007

Related Keywords:

  • Colorectal Cancer
  • nitrous oxide
  • cancer recurrence
  • colorectal surgery
  • Colorectal Neoplasms
  • Recurrence

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