Nitrous Oxide and Risk of Cancer Recurrence After Colorectal Surgery: A Randomized, Blinded Study
- Registration Number
- NCT00781352
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 408
- Subjects age 18-18
- ASA status 1-3
- Informed consent
- Acute bowel obstruction
- Minor colon surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group 2 nitrogen Colorectal surgery with nitrogen administration group 1 nitrous oxide Colorectal surgery with 65% nitrous oxide administration
- Primary Outcome Measures
Name Time Method 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. 270 days post surgery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medical University of Vienna
🇦🇹Vienna, Austria