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

Phase 3

Completed

• Conditions: Pain
• Interventions: Other: bowel insufflation gas

• Registration Number: NCT01450202
• Lead Sponsor: Inje University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-04
• Study First Submitted QC: 2011-10-11
• Study First Posted: 2011-10-12
• Study Start: 2011-11
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-24
• Last Update Posted: 2012-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Air insufflation, colonoscopy, esophagogastroduodenoscopy	bowel insufflation gas	-
CO2 insufflation, colonoscopy, esophagogastroduodenoscopy	bowel insufflation gas	-

Primary Outcome Measures

Name	Time	Method
post-procedural pain	3 months	The primary end point of the study was to assess post-procedural pain according to VAS scale

Secondary Outcome Measures

Name	Time	Method
abdominal distention	3 months	abdominal distention using measurement of patient waist circumferences
ETCO2	3 months	Measure ETCO2 using nasal cannula

Trial Locations

Locations (1)

Haeundae Paik Hospital; 🇰🇷 Busan, Korea, Republic of