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| Sponsors and Collaborators: |
Outcomes Research Consortium The Cleveland Clinic |
|---|---|
| Information provided by: | Outcomes Research Consortium |
| ClinicalTrials.gov Identifier: | NCT00781352 |
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 III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Nitrous Oxide Does Not Increase the Risk of Cancer Recurrence After Colorectal Surgery: A Randomized, Blinded Study |
| 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 |
|---|---|
|
group 1: Active Comparator
Colorectal surgery with 65% nitrous oxide administration
|
Drug: nitrous oxide
65% nitrous oxide administered during surgery
|
|
group 2: Active Comparator
Colorectal surgery with nitrogen administration
|
Drug: nitrogen
Nitrogen administration during surgery
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Austria | |
| Medical University of Vienna | |
| Vienna, Austria, 1090 | |
| Principal Investigator: | Edith Fleischmann, M.D. | Medical University of Vienna |
| Study Director: | Daniel I Sessler, M.D. | Cleveland Clinic |
More Information
| Responsible Party: | Medical University of Vienna ( Edith Fleischmann ) |
| Study ID Numbers: | efno1008 |
| Study First Received: | October 27, 2008 |
| Last Updated: | October 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00781352 |
| Health Authority: | Austria: Ethikkommission |
|
nitrous oxide cancer recurrence colorectal surgery |
|
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Nitrous Oxide Colonic Diseases Gastrointestinal Neoplasms |
Intestinal Diseases Rectal Diseases Intestinal Neoplasms Recurrence Colorectal Neoplasms |
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Disease Attributes Physiological Effects of Drugs Central Nervous System Depressants Anesthetics Pharmacologic Actions Anesthetics, Inhalation Neoplasms Neoplasms by Site |
Pathologic Processes Anesthetics, General Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents |
