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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Active Comparator | Colorectal surgery with 65% nitrous oxide administration |
|
| group 2 | Active Comparator | Colorectal surgery with nitrogen administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nitrous oxide | Drug | 65% nitrous oxide administered during surgery |
| |
| Measure | Description | 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. | 270 days post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edith Fleischmann, M.D. | Medical University of Vienna | Principal Investigator |
| Daniel I Sessler, M.D. | The Cleveland Clinic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19192300 | Derived | 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. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D009609 | Nitrous Oxide |
| D009584 | Nitrogen |
| ID | Term |
|---|---|
| D009589 | Nitrogen Oxides |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
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| nitrogen |
| Drug |
Nitrogen administration during surgery |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D010087 |
| Oxides |
| D017601 | Oxygen Compounds |
| D004602 | Elements |