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

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ClinicalTrials.gov Identifier: NCT01415076
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : September 5, 2012
Sponsor:
Information provided by (Responsible Party):
Peng-Jen Chen, Tri-Service General Hospital

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
Outpatients Procedure: Insufflation with CO2 Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : September 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. abdominal pain during and after colonoscopy [ Time Frame: 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 [ Time Frame: One day ]
  2. colonoscopic cecal intubation time [ Time Frame: One day ]
  3. completeness of intubation [ Time Frame: One day ]
  4. loop formation [ Time Frame: One day ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Peng-Jen Chen, Dr., Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT01415076     History of Changes
Other Study ID Numbers: TSGH-C99-062
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: September 5, 2012
Last Verified: September 2012