Safety and Efficacy of Carbon Dioxide Insufflation During Colonoscopy With Consecutive Esophagogastroduodenoscopy in Reduction of Abdominal Pain in Sedated Outpatients (COCE)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Other: bowel insufflation gas |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Diagnostic |
| 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 |
- post-procedural pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]The primary end point of the study was to assess post-procedural pain according to VAS scale
- abdominal distention [ Time Frame: 3 months ] [ Designated as safety issue: No ]abdominal distention using measurement of patient waist circumferences
- ETCO2 [ Time Frame: 3 months ] [ Designated as safety issue: No ]Measure ETCO2 using nasal cannula
| Enrollment: | 100 |
| Study Start Date: | November 2011 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Air insufflation, colonoscopy, esophagogastroduodenoscopy |
Other: bowel insufflation gas
air insufflation, during colonoscopy and esophagogastroduodenoscopy
Other Name: bowel insufflation gas
|
| Active Comparator: CO2 insufflation, colonoscopy, esophagogastroduodenoscopy |
Other: bowel insufflation gas
CO2 insufflation, during colonoscopy and esophagogastroduodenoscopy
Other Name: bowel insufflation gas
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Eun Hee Seo, MD, principal investigator, Inje University |
| ClinicalTrials.gov Identifier: | NCT01450202 History of Changes |
| Other Study ID Numbers: | Oct 2011-01 |
| Study First Received: | October 4, 2011 |
| Last Updated: | June 24, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Inje University:
|
Carbon dioxide insufflation Colonoscopy Esophagogastroduodenoscopy |
Bowel insufflation Postprocedure pain Pain Due to Certain Specified Procedures |
Additional relevant MeSH terms:
|
Abdominal Pain Pain Signs and Symptoms Signs and Symptoms, Digestive |
ClinicalTrials.gov processed this record on May 16, 2013