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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:
ClinicalTrials.gov Identifier:
NCT01450202
First Posted: October 12, 2011
Last Update Posted: June 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eun Hee Seo, MD, Inje University
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Eun Hee Seo, MD, Inje University:

Primary Outcome Measures:
  • post-procedural pain [ Time Frame: 3 months ]
    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 ]
    abdominal distention using measurement of patient waist circumferences

  • ETCO2 [ Time Frame: 3 months ]
    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
Active Comparator: CO2 insufflation, colonoscopy, esophagogastroduodenoscopy Other: bowel insufflation gas
CO2 insufflation, during colonoscopy and esophagogastroduodenoscopy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01450202


Locations
Korea, Republic of
Haeundae Paik Hospital
Busan, Korea, Republic of, 612-030
Sponsors and Collaborators
Inje University
  More Information

Responsible Party: Eun Hee Seo, MD, principal investigator, Inje University
ClinicalTrials.gov Identifier: NCT01450202     History of Changes
Other Study ID Numbers: Oct 2011-01
First Submitted: October 4, 2011
First Posted: October 12, 2011
Last Update Posted: June 26, 2012
Last Verified: June 2012

Keywords provided by Eun Hee Seo, MD, Inje University:
Carbon dioxide insufflation
Colonoscopy
Esophagogastroduodenoscopy
Bowel insufflation
Postprocedure pain
Pain Due to Certain Specified Procedures

Additional relevant MeSH terms:
Abdominal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive