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Nitrous Oxide and Risk of Cancer Recurrence After Colorectal Surgery: A Randomized, Blinded Study

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ClinicalTrials.gov Identifier: NCT00781352
Recruitment Status : Completed
First Posted : October 29, 2008
Last Update Posted : June 29, 2016
Sponsor:
Information provided by:
The Cleveland Clinic

Brief Summary:
This study was developed to test the hypothesis that the risk of colorectal cancer recurrence was similar in patients who were randomly assigned to 65% nitrous oxide or nitrogen during colorectal surgery.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: nitrous oxide Drug: nitrogen Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Nitrous Oxide Does Not Increase the Risk of Cancer Recurrence After Colorectal Surgery: A Randomized, Blinded Study
Study Start Date : November 1998
Actual Primary Completion Date : November 2003
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: group 1
Colorectal surgery with 65% nitrous oxide administration
Drug: nitrous oxide
65% nitrous oxide administered during surgery
Active Comparator: group 2
Colorectal surgery with nitrogen administration
Drug: nitrogen
Nitrogen administration during surgery



Primary Outcome Measures :
  1. 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. [ Time Frame: 270 days post surgery ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects age 18-18
  • ASA status 1-3
  • Informed consent

Exclusion Criteria:

  • Acute bowel obstruction
  • Minor colon surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781352


Locations
Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Edith Fleischmann, M.D. Medical University of Vienna
Study Director: Daniel I Sessler, M.D. The Cleveland Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Edith Fleischmann, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00781352     History of Changes
Other Study ID Numbers: efno1008
First Posted: October 29, 2008    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The Cleveland Clinic:
nitrous oxide
cancer recurrence
colorectal surgery

Additional relevant MeSH terms:
Colorectal Neoplasms
Recurrence
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Disease Attributes
Pathologic Processes
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents