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

This study has been completed.
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00781352
First received: October 27, 2008
Last updated: October 28, 2008
Last verified: October 2008
  Purpose

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 Intervention Phase
Colorectal Cancer
Drug: nitrous oxide
Drug: nitrogen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Nitrous Oxide Does Not Increase the Risk of Cancer Recurrence After Colorectal Surgery: A Randomized, Blinded Study

Resource links provided by NLM:


Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • 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 surrgery ] [ Designated as safety issue: No ]

Enrollment: 408
Study Start Date: November 1998
Study Completion Date: March 2007
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781352

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

No publications provided

Responsible Party: Edith Fleischmann, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00781352     History of Changes
Other Study ID Numbers: efno1008
Study First Received: October 27, 2008
Last Updated: October 28, 2008
Health Authority: Austria: Ethikkommission

Keywords provided by Outcomes Research Consortium:
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
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 20, 2014