The Optimal Timing of Carbon Dioxide Insufflation During Colonoscopy in Unsedated Patients
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 10, 2011
CompletedFirst Posted
Study publicly available on registry
August 11, 2011
CompletedSeptember 5, 2012
September 1, 2012
9 months
August 10, 2011
September 3, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
abdominal pain during and after colonoscopy
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.
One day
Secondary Outcomes (4)
delayed bleeding
One day
colonoscopic cecal intubation time
One day
completeness of intubation
One day
loop formation
One day
Study Arms (2)
Insertion without CO2 insufflation
PLACEBO COMPARATORPatients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list.
Insertion with CO2
EXPERIMENTALPatients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list.
Interventions
Patients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list.
Eligibility Criteria
You may qualify if:
- patients with an appropriate indication for colonoscopy were considered eligible.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Gastroenterology, Tri-Service General Hospital
Taipei, 114, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tsai-Yuan Hsieh, MD.PhD
Division of Gastroenterology, Tri-Service General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
August 10, 2011
First Posted
August 11, 2011
Study Start
September 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
September 5, 2012
Record last verified: 2012-09