Safety and Efficacy of Carbon Dioxide Insufflation During Colonoscopy With Consecutive Esophagogastroduodenoscopy in Reduction of Abdominal Pain in Sedated Outpatients (COCE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eun Hee Seo, MD, Inje University
ClinicalTrials.gov Identifier:
NCT01450202
First received: October 4, 2011
Last updated: June 24, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


Further study details as provided by Inje University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450202

Locations
Korea, Republic of
Haeundae Paik Hospital
Busan, Korea, Republic of, 612-030
Sponsors and Collaborators
Inje University
  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 October 23, 2014