Skip to main content
OpenTrials
Completed

NCT Number: NCT01450202

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Haeundae Paik Hospital

Busan, 612-030, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bowel insufflation gas

Other

air insufflation, during colonoscopy and esophagogastroduodenoscopy

Primary outcomes

  1. 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 outcomes

  1. abdominal distention

    Time frame: 3 months

    abdominal distention using measurement of patient waist circumferences

  2. ETCO2

    Time frame: 3 months

    Measure ETCO2 using nasal cannula

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

Carbon Dioxide Insufflation During Colonoscopy With Consecutive EGD is Safe and Decreases Abdominal Pain in Sedated Outpatients: a Randomized, Double-blind, Controlled Trial

Acronym: COCE

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Oct 12, 2011
Registry last updated
Jun 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.