Nitrous Oxide and Risk of Cancer Recurrence After Colorectal Surgery: A Randomized, Blinded Study
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
nitrous oxide
nitrogen
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring nitrous oxide, cancer recurrence, colorectal surgery
Eligibility Criteria
Inclusion Criteria:
- Subjects age 18-18
- ASA status 1-3
- Informed consent
Exclusion Criteria:
- Acute bowel obstruction
- Minor colon surgery
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group 1
group 2
Arm Description
Colorectal surgery with 65% nitrous oxide administration
Colorectal surgery with nitrogen administration
Outcomes
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00781352
Brief Title
Nitrous Oxide and Risk of Cancer Recurrence After Colorectal Surgery: A Randomized, Blinded Study
Official Title
Nitrous Oxide Does Not Increase the Risk of Cancer Recurrence After Colorectal Surgery: A Randomized, Blinded Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
November 1998 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
nitrous oxide, cancer recurrence, colorectal surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
408 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Active Comparator
Arm Description
Colorectal surgery with 65% nitrous oxide administration
Arm Title
group 2
Arm Type
Active Comparator
Arm Description
Colorectal surgery with nitrogen administration
Intervention Type
Drug
Intervention Name(s)
nitrous oxide
Intervention Description
65% nitrous oxide administered during surgery
Intervention Type
Drug
Intervention Name(s)
nitrogen
Intervention Description
Nitrogen administration during surgery
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects age 18-18
ASA status 1-3
Informed consent
Exclusion Criteria:
Acute bowel obstruction
Minor colon surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edith Fleischmann, M.D.
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel I Sessler, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Director
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19192300
Citation
Fleischmann E, Marschalek C, Schlemitz K, Dalton JE, Gruenberger T, Herbst F, Kurz A, Sessler DI. Nitrous oxide may not increase the risk of cancer recurrence after colorectal surgery: a follow-up of a randomized controlled trial. BMC Anesthesiol. 2009 Feb 3;9:1. doi: 10.1186/1471-2253-9-1.
Results Reference
derived
Learn more about this trial
Nitrous Oxide and Risk of Cancer Recurrence After Colorectal Surgery: A Randomized, Blinded Study
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