Back to resultsSafety and Efficacy of Carbon Dioxide Insufflation During Colonoscopy With Consecutive Esophagogastroduodenoscopy in Reduction of Abdominal Pain in Sedated Outpatients (COCE)
Primary Purpose
Pain
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
bowel insufflation gas
bowel insufflation gas
Sponsored by
About this trial
This is an interventional diagnostic trial for Pain focused on measuring Carbon dioxide insufflation, Colonoscopy, Esophagogastroduodenoscopy, Bowel insufflation, Postprocedure pain, Pain Due to Certain Specified Procedures
Eligibility Criteria
Inclusion Criteria:
- outpatients between the ages of 18 and 70 years who are scheduled for colonoscopy with consecutive EGD
Exclusion Criteria:
- age < 18 or > 70 years
- pregnancy
- breast feeding
- chronic obstructive lung disease (COPD)
- known CO2 retention and refusal to participate in the study
Sites / Locations
- Haeundae Paik Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Air insufflation, colonoscopy, esophagogastroduodenoscopy
CO2 insufflation, colonoscopy, esophagogastroduodenoscopy
Arm Description
Outcomes
Primary Outcome Measures
post-procedural pain
The primary end point of the study was to assess post-procedural pain according to VAS scale
Secondary Outcome Measures
abdominal distention
abdominal distention using measurement of patient waist circumferences
ETCO2
Measure ETCO2 using nasal cannula
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01450202
Brief Title
Safety and Efficacy of Carbon Dioxide Insufflation During Colonoscopy With Consecutive Esophagogastroduodenoscopy in Reduction of Abdominal Pain in Sedated Outpatients
Acronym
COCE
Official Title
Carbon Dioxide Insufflation During Colonoscopy With Consecutive EGD is Safe and Decreases Abdominal Pain in Sedated Outpatients: a Randomized, Double-blind, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inje University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Carbon dioxide insufflation, Colonoscopy, Esophagogastroduodenoscopy, Bowel insufflation, Postprocedure pain, Pain Due to Certain Specified Procedures
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Air insufflation, colonoscopy, esophagogastroduodenoscopy
Arm Type
Placebo Comparator
Arm Title
CO2 insufflation, colonoscopy, esophagogastroduodenoscopy
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
bowel insufflation gas
Intervention Description
air insufflation, during colonoscopy and esophagogastroduodenoscopy
Intervention Type
Other
Intervention Name(s)
bowel insufflation gas
Intervention Description
CO2 insufflation, during colonoscopy and esophagogastroduodenoscopy
Primary Outcome Measure Information:
Title
post-procedural pain
Description
The primary end point of the study was to assess post-procedural pain according to VAS scale
Time Frame
3 months
Secondary Outcome Measure Information:
Title
abdominal distention
Description
abdominal distention using measurement of patient waist circumferences
Time Frame
3 months
Title
ETCO2
Description
Measure ETCO2 using nasal cannula
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
outpatients between the ages of 18 and 70 years who are scheduled for colonoscopy with consecutive EGD
Exclusion Criteria:
age < 18 or > 70 years
pregnancy
breast feeding
chronic obstructive lung disease (COPD)
known CO2 retention and refusal to participate in the study
Facility Information:
Facility Name
Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
612-030
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Carbon Dioxide Insufflation During Colonoscopy With Consecutive Esophagogastroduodenoscopy in Reduction of Abdominal Pain in Sedated Outpatients
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