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The Optimal Timing of Carbon Dioxide Insufflation During Colonoscopy in Unsedated Patients

Sponsor
Tri-Service General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01415076
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
9
Duration (Months)
22.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Insufflation of carbon dioxide (CO2) instead of air can reduce pain resulting from colon distension after colonoscopy because CO2 is rapidly absorbed from the colon and excreted through the lungs. This reduces the effects of colonic distension and minimizes intracolonic gas at the end of the examination. The aims of the study were to evaluate the timing of administering CO2 insufflation and to identify predictors of discomfort for colonoscopy.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Insufflation with CO2
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Health Services Research
Official Title:
The Optimal Timing of Carbon Dioxide Insufflation During Colonoscopy in Unsedated Patients
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Insertion without CO2 insufflation

Patients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list.

Procedure: Insufflation with CO2
Patients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list.
Other Names:
  • the Olympus UCR Endoscopic CO2 Regulation Unit

    		•
    Experimental: Insertion with CO2

    Patients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list.

    Procedure: Insufflation with CO2
    Patients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list.
    Other Names:
  • the Olympus UCR Endoscopic CO2 Regulation Unit

    		•

    Outcome Measures

    Primary Outcome Measures

    1. abdominal pain during and after colonoscopy [One day]

      Pain was recorded on a ten-point visual analog scale (0- no pain, 10- worst imaginable pain) at left-sided colonoscopic insertion, right-sided colonoscopic insertion, and at 1, 3, 6, and 24 hours postprocedure.

    Secondary Outcome Measures

    1. delayed bleeding [One day]

    2. colonoscopic cecal intubation time [One day]

    3. completeness of intubation [One day]

    4. loop formation [One day]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • patients with an appropriate indication for colonoscopy were considered eligible.
    Exclusion Criteria:
    • Exclusion criteria included severe hematochezia, acute colonic pseudo-obstruction, known obstructive lesions, age <18 years, prior colon resection, fulminant colitis, chronic obstructive pulmonary disease requiring oxygen, and a medical history of CO2 retention. Patients that required only a partial colonoscopy or were unable to read or understand Chinese were also excluded.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Division of Gastroenterology, Tri-Service General Hospital Taipei Taiwan 114

    Sponsors and Collaborators

    • Tri-Service General Hospital

    Investigators

    • Study Chair: Tsai-Yuan Hsieh, MD.PhD, Division of Gastroenterology, Tri-Service General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peng-Jen Chen, Dr., Tri-Service General Hospital
    ClinicalTrials.gov Identifier:
    NCT01415076
    Other Study ID Numbers:
    • TSGH-C99-062
    First Posted:
    Aug 11, 2011
    Last Update Posted:
    Sep 5, 2012
    Last Verified:
    Sep 1, 2012

    Study Results

    No Results Posted as of Sep 5, 2012