NCT00781352

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
408

participants targeted

Target at P50-P75 for phase_3 colorectal-cancer

Timeline
Completed

Started Nov 1998

Longer than P75 for phase_3 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1998

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2008

Completed
Last Updated

June 29, 2016

Status Verified

June 1, 2016

Enrollment Period

5 years

First QC Date

October 27, 2008

Last Update Submit

June 28, 2016

Conditions

Colorectal Cancer

Keywords

nitrous oxidecancer recurrencecolorectal surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

group 1

ACTIVE COMPARATOR

Colorectal surgery with 65% nitrous oxide administration

Drug: nitrous oxide

group 2

ACTIVE COMPARATOR

Colorectal surgery with nitrogen administration

Drug: nitrogen

Interventions

nitrous oxideDRUG

65% nitrous oxide administered during surgery

group 1
nitrogenDRUG

Nitrogen administration during surgery

group 2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Acute bowel obstruction
  • Minor colon surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

  • 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.

    PMID: 19192300DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Nitrous OxideNitrogen

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Nitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen CompoundsElements

Study Officials

  • Edith Fleischmann, M.D.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

  • Daniel I Sessler, M.D.

    The Cleveland Clinic

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2008

First Posted

October 29, 2008

Study Start

November 1, 1998

Primary Completion

November 1, 2003

Study Completion

March 1, 2007

Last Updated

June 29, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)