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

NCT ID: NCT01450202

Last Updated: 2012-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-01-31

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Air insufflation, colonoscopy, esophagogastroduodenoscopy

Group Type: PLACEBO_COMPARATOR

bowel insufflation gas

Intervention Type: OTHER

air insufflation, during colonoscopy and esophagogastroduodenoscopy

CO2 insufflation, colonoscopy, esophagogastroduodenoscopy

Group Type: ACTIVE_COMPARATOR

bowel insufflation gas

Intervention Type: OTHER

CO2 insufflation, during colonoscopy and esophagogastroduodenoscopy

Interventions

bowel insufflation gas

air insufflation, during colonoscopy and esophagogastroduodenoscopy

Intervention Type: OTHER

bowel insufflation gas

CO2 insufflation, during colonoscopy and esophagogastroduodenoscopy

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inje University

OTHER

Sponsor Role: lead

Responsible Party

Eun Hee Seo, MD

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Haeundae Paik Hospital

Busan, , South Korea

Countries

South Korea

Other Identifiers

Oct 2011-01

Identifier Type: -

Identifier Source: org_study_id