We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01415076
First Posted: August 11, 2011
Last Update Posted: September 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Peng-Jen Chen, Tri-Service General Hospital
  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
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

Resource links provided by NLM:


Further study details as provided by Peng-Jen Chen, Tri-Service General Hospital:

Primary Outcome Measures:
  • 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:
  • delayed bleeding [ Time Frame: One day ]
  • colonoscopic cecal intubation time [ Time Frame: One day ]
  • completeness of intubation [ Time Frame: One day ]
  • loop formation [ Time Frame: One day ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

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 Submitted: August 10, 2011
First Posted: August 11, 2011
Last Update Posted: September 5, 2012
Last Verified: September 2012