Safety and Efficacy of Carbon Dioxide Insufflation During Colonoscopy With Consecutive Esophagogastroduodenoscopy in Reduction of Abdominal Pain in Sedated Outpatients
COCE
Carbon Dioxide Insufflation During Colonoscopy With Consecutive EGD is Safe and Decreases Abdominal Pain in Sedated Outpatients: a Randomized, Double-blind, Controlled Trial
1 other identifier
interventional
100
1 country
1
Brief Summary
Compared with performing each procedure individually, performing two combined procedures such as colonoscopy consecutive Esophagogastroduodenoscopy (EGD) cause more bowel gases, abdominal distension and post-procedure pain because of longer procedure time related to more bowel insufflated gas than one procedure. To the best of the investigators knowledge, there has been no randomized controlled trial of CO2 versus air for insufflations during combined two procedures, colonoscopy with consecutive EGD. And there are a few well randomized trials concerned CO2 insufflation in patients receiving sedation during colonoscopy. The aim of the present study was to evaluate the efficacy of CO2 in reducing post-procedural abdominal pain and distension during colonoscopy consecutive EGD and to confirm the safety of CO2 insufflation when it is used during procedure in sedated outpatients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 pain
Started Nov 2011
Shorter than P25 for phase_3 pain
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
First Submitted
Initial submission to the registry
October 4, 2011
CompletedFirst Posted
Study publicly available on registry
October 12, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJune 26, 2012
June 1, 2012
1 month
October 4, 2011
June 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
post-procedural pain
The primary end point of the study was to assess post-procedural pain according to VAS scale
3 months
Secondary Outcomes (2)
abdominal distention
3 months
ETCO2
3 months
Study Arms (2)
Air insufflation, colonoscopy, esophagogastroduodenoscopy
PLACEBO COMPARATORCO2 insufflation, colonoscopy, esophagogastroduodenoscopy
ACTIVE COMPARATORInterventions
air insufflation, during colonoscopy and esophagogastroduodenoscopy
Eligibility Criteria
You may qualify if:
- outpatients between the ages of 18 and 70 years who are scheduled for colonoscopy with consecutive EGD
You may not qualify if:
- age \< 18 or \> 70 years
- pregnancy
- breast feeding
- chronic obstructive lung disease (COPD)
- known CO2 retention and refusal to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inje Universitylead
Study Sites (1)
Haeundae Paik Hospital
Busan, 612-030, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
October 4, 2011
First Posted
October 12, 2011
Study Start
November 1, 2011
Primary Completion
December 1, 2011
Study Completion
January 1, 2012
Last Updated
June 26, 2012
Record last verified: 2012-06