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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peng-Jen Chen, Tri-Service General Hospital
ClinicalTrials.gov Identifier:
NCT01415076
First received: August 10, 2011
Last updated: September 3, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention
Outpatients
 Procedure: Insufflation with CO2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: The Optimal Timing of Carbon Dioxide Insufflation During Colonoscopy in Unsedated Patients

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by Tri-Service General Hospital:

Primary Outcome Measures:
  • abdominal pain during and after colonoscopy [ Time Frame: One day ] [ Designated as safety issue: No ]
    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:
  • delayed bleeding [ Time Frame: One day ] [ Designated as safety issue: No ]
  • colonoscopic cecal intubation time [ Time Frame: One day ] [ Designated as safety issue: No ]
  • completeness of intubation [ Time Frame: One day ] [ Designated as safety issue: No ]
  • loop formation [ Time Frame: One day ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: September 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: the Olympus UCR Endoscopic CO2 Regulation Unit

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415076

Locations
Taiwan
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
  More Information

No publications provided

Responsible Party: Peng-Jen Chen, Dr., Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT01415076     History of Changes
Other Study ID Numbers: TSGH-C99-062
Study First Received: August 10, 2011
Last Updated: September 3, 2012
Health Authority: Taiwan: Department of Health

ClinicalTrials.gov processed this record on June 17, 2013