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Carbon Dioxide Insufflation Colonoscopy in IBD Patients

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.
 
ClinicalTrials.gov Identifier: NCT02563132
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
Premysl Falt, M.D., Ph.D., Vitkovice Hospital

Tracking Information
First Submitted Date  ICMJE September 28, 2015
First Posted Date  ICMJE September 29, 2015
Last Update Posted Date June 1, 2016
Study Start Date  ICMJE October 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Carbon Dioxide Insufflation Colonoscopy in IBD Patients
Official Title  ICMJE Carbon Dioxide Insufflation Colonoscopy in Inflammatory Bowel Disease Patients
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Colonoscopy
  • Carbon Dioxide
  • Inflammatory Bowel Disease
Intervention  ICMJE Procedure: Carbon dioxide insufflation
Carbon dioxide insufflation during diagnostic colonoscopy
Study Arms  ICMJE
  • Experimental: Carbon dioxide insufflation colonoscopy (CO2)
    Carbon dioxide during both insertion and withdrawal phase of the colonoscopy.
    Intervention: Procedure: Carbon dioxide insufflation
  • No Intervention: Air insufflation colonoscopy (AI)
    Air insufflation during both insertion and withdrawal phase of the colonoscopy.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2015)
64
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02563132
Other Study ID Numbers  ICMJE DDC VN 08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Premysl Falt, M.D., Ph.D., Vitkovice Hospital
Study Sponsor  ICMJE Vitkovice Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vitkovice Hospital
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP