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Carbon Dioxide Insufflation Colonoscopy in IBD Patients

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colonoscopy Carbon Dioxide Inflammatory Bowel Disease Procedure: Carbon dioxide insufflation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Carbon Dioxide Insufflation Colonoscopy in Inflammatory Bowel Disease Patients
Study Start Date : October 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563132


Locations
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Czech Republic
Digestive Diseases Center - Vitkovice Hospital
Ostrava, Czech Republic, 703 84
Sponsors and Collaborators
Vitkovice Hospital
More Information
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Responsible Party: Premysl Falt, M.D., Ph.D., Vitkovice Hospital
ClinicalTrials.gov Identifier: NCT02563132     History of Changes
Other Study ID Numbers: DDC VN 08
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Keywords provided by Premysl Falt, M.D., Ph.D., Vitkovice Hospital:
colonoscopy
carbon dioxide
inflammatory bowel disease
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis