Carbon Dioxide Insufflation Colonoscopy in IBD Patients

May 28, 2016 updated by: Premysl Falt, M.D., Ph.D., Vitkovice Hospital

Carbon Dioxide Insufflation Colonoscopy in Inflammatory Bowel Disease Patients

Carbon dioxide insufflation during colonoscopy significantly reduces discomfort (pain, bloating and flatulence) after the procedure. So far, it has not been studied in inflammatory bowel disease patients. The study was designed to evaluate discomfort after the carbon dioxide insufflation colonoscopy in comparison to standard air insufflation colonoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Carbon dioxide insufflation during colonoscopy significantly reduces discomfort (pain, bloating and flatulence) during up to 24 hours after the procedure. So far, it has not been studied in inflammatory bowel disease patients who represent specific patient population indicated for colonoscopy. They are characterized by younger age, structural changes of the colon including intestinal resections and need for repeated and frequently difficult procedures.The study was designed to evaluate discomfort during 24 hours after the carbon dioxide insufflation colonoscopy in comparison to standard air insufflation colonoscopy.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Ostrava, Czech Republic, 703 84
        • Digestive Diseases Center - Vitkovice Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • known diagnosis of Crohn´s disease and ulcerative colitis
  • indication for diagnostic colonoscopy
  • informed consent
  • unsedated or minimally sedated procedure (< 3 mg of midazolam)

Exclusion Criteria:

  • planned incomplete or therapeutic procedure
  • deep sedation or general anesthesia
  • intestinal resection longer than ileocecal resection
  • isolated gastroduodenal or jejunal location of Crohn´s disease (L4)
  • ulcerative proctitis (E1)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carbon dioxide insufflation colonoscopy (CO2)
Carbon dioxide during both insertion and withdrawal phase of the colonoscopy.
Procedure: Carbon dioxide insufflation
Carbon dioxide insufflation during diagnostic colonoscopy
No Intervention: Air insufflation colonoscopy (AI)
Air insufflation during both insertion and withdrawal phase of the colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bloating score 1 hour after the colonoscopy
Time Frame: 1 hour
Bloating severity on continuous scale 0-10 (0 = none, 10 = worst) 1 hour after colonoscopy
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vitkovice Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 29, 2015

Study Record Updates

Last Update Posted (Estimate)

June 1, 2016

Last Update Submitted That Met QC Criteria

May 28, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DDC VN 08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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