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

June 28, 2016 updated by: The Cleveland Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

408

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Acute bowel obstruction
  • Minor colon surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
270 days post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1998

Primary Completion (Actual)

November 1, 2003

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

October 27, 2008

First Submitted That Met QC Criteria

October 28, 2008

First Posted (Estimate)

October 29, 2008

Study Record Updates

Last Update Posted (Estimate)

June 29, 2016

Last Update Submitted That Met QC Criteria

June 28, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • efno1008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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