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Carbon Dioxide Insufflation Colonoscopy in IBD Patients

Primary Purpose

Colonoscopy, Carbon Dioxide, Inflammatory Bowel Disease

Status
Completed
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
Carbon dioxide insufflation
Sponsored by
Vitkovice Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonoscopy focused on measuring colonoscopy, carbon dioxide, inflammatory bowel disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Digestive Diseases Center - Vitkovice Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Carbon dioxide insufflation colonoscopy (CO2)

Air insufflation colonoscopy (AI)

Arm Description

Carbon dioxide during both insertion and withdrawal phase of the colonoscopy.

Air insufflation during both insertion and withdrawal phase of the colonoscopy.

Outcomes

Primary Outcome Measures

Bloating score 1 hour after the colonoscopy
Bloating severity on continuous scale 0-10 (0 = none, 10 = worst) 1 hour after colonoscopy

Secondary Outcome Measures

Full Information

First Posted
September 28, 2015
Last Updated
May 28, 2016
Sponsor
Vitkovice Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02563132
Brief Title
Carbon Dioxide Insufflation Colonoscopy in IBD Patients
Official Title
Carbon Dioxide Insufflation Colonoscopy in Inflammatory Bowel Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vitkovice Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonoscopy, Carbon Dioxide, Inflammatory Bowel Disease
Keywords
colonoscopy, carbon dioxide, inflammatory bowel disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carbon dioxide insufflation colonoscopy (CO2)
Arm Type
Experimental
Arm Description
Carbon dioxide during both insertion and withdrawal phase of the colonoscopy.
Arm Title
Air insufflation colonoscopy (AI)
Arm Type
No Intervention
Arm Description
Air insufflation during both insertion and withdrawal phase of the colonoscopy.
Intervention Type
Procedure
Intervention Name(s)
Carbon dioxide insufflation
Intervention Description
Carbon dioxide insufflation during diagnostic colonoscopy
Primary Outcome Measure Information:
Title
Bloating score 1 hour after the colonoscopy
Description
Bloating severity on continuous scale 0-10 (0 = none, 10 = worst) 1 hour after colonoscopy
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Digestive Diseases Center - Vitkovice Hospital
City
Ostrava
ZIP/Postal Code
703 84
Country
Czech Republic

12. IPD Sharing Statement

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