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Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease (CO2-IBD)

Primary Purpose

Inflammatory Bowel Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
carbon dioxide insufflation during colonoscopy
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Inflammatory Bowel Diseases focused on measuring Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis, Carbon Dioxide (CO2), Colonoscopy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with inflammatory bowel disease
  • Indication for colonoscopy
  • Age 18-80 years
  • signed consent form

Exclusion Criteria:

  • Consent form not signed
  • Age < 18 or above 80 yrs
  • Pregnancy or Breast-Feeding

Sites / Locations

  • Unversity Clinic MuensterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

No Intervention

Active Comparator

No Intervention

Arm Label

CD patient with CO2 insufflation

CD patient with air insufflation

UC patient with CO2 insufflation

UC patient with air insufflation

Arm Description

The investigators aim to include 76 Crohn's disease (CD) patients undergoing colonoscopy in whom CO2 insufflation during endoscopy should be used.

The investigators aim to include 76 Crohn's disease patients undergoing colonoscopy in whom air insufflation during endoscopy should be used.

The investigators aim to include 76 ulcerative colitis patients (UC) undergoing colonoscopy in whom CO2 insufflation during endoscopy should be used.

The investigators aim to include 76 ulcerative colitis patients undergoing colonoscopy in whom air insufflation during endoscopy should be used.

Outcomes

Primary Outcome Measures

Comparison of colonoscopy related abdominal pain 1 hour after examination assessed by a visual analogue pain scale in patients with inflammatory bowel disease
For pain assessment a visual analogue scale will be used. For the primary outcome measure, the investigators will compare the difference in pain level 1 hour after colonoscopy (comparison of carbon dioxide to air insufflation).

Secondary Outcome Measures

Comparison of colonoscopy related abdominal pain 3 hours, 6 hours and 24 hours after examination assessed by a visual analogue pain scale in patients with inflammatory bowel disease
For pain assessment a visual analogue scale will be used. For the secondary outcome measure, the investigators will compare the differences in pain level 3 hours, 6 hours and 24 hours after colonoscopy (comparison of carbon dioxide to air insufflation).

Full Information

First Posted
September 5, 2017
Last Updated
June 15, 2020
Sponsor
University Hospital Muenster
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1. Study Identification

Unique Protocol Identification Number
NCT03282786
Brief Title
Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease
Acronym
CO2-IBD
Official Title
Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 3, 2017 (Actual)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Muenster

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with inflammatory bowel disease (IBD) frequently undergo endoscopic examination and may suffer from diagnostic procedures. Independent from IBD patients, colonoscopy is usually performed using air insufflation, however recent data indicates a superior role of carbon dioxide (CO2) as an insufflation gas during colonoscopy. Using CO2 leads to a lower degree of patient's discomfort. The role of CO2 as an insufflation gas for colonoscopy in IBD patients remains undetermined, wherefore this study aims to address this issue.
Detailed Description
Patients with inflammatory bowel disease (IBD) suffer from a chronic inflammatory course of disease. To stage the course of disease endoscopic procedures including colonoscopy may be required and especially IBD patients with their inflamed gut may suffer from repetitive endoscopic examinations including colonoscopy. Independent from IBD patients, colonoscopy is usually performed using air insufflation, however recent data indicates a superior role of carbon dioxide (CO2) as an insufflation gas during colonoscopy. Using CO2 leads to a lower degree of patient's discomfort which has been mainly demonstrated in groups of patients undergoing cancer surveillance colonoscopies and who do not suffer from IBD. Therefore the role of CO2 as an insufflation gas for colonoscopy in IBD patients remains undetermined and this study aims to address this issue. For pain assessment a visual analogue scale will be used. As the primary outcome measure, the investigators will compare the differences in pain level 1h after colonoscopy (comparison of carbon dioxide to air insufflation). For the secondary outcome measure the investigators will compare the differences in pain level 3h, 6h and 24h after colonoscopy (comparison of carbon dioxide to air insufflation).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
Keywords
Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis, Carbon Dioxide (CO2), Colonoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
304 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CD patient with CO2 insufflation
Arm Type
Active Comparator
Arm Description
The investigators aim to include 76 Crohn's disease (CD) patients undergoing colonoscopy in whom CO2 insufflation during endoscopy should be used.
Arm Title
CD patient with air insufflation
Arm Type
No Intervention
Arm Description
The investigators aim to include 76 Crohn's disease patients undergoing colonoscopy in whom air insufflation during endoscopy should be used.
Arm Title
UC patient with CO2 insufflation
Arm Type
Active Comparator
Arm Description
The investigators aim to include 76 ulcerative colitis patients (UC) undergoing colonoscopy in whom CO2 insufflation during endoscopy should be used.
Arm Title
UC patient with air insufflation
Arm Type
No Intervention
Arm Description
The investigators aim to include 76 ulcerative colitis patients undergoing colonoscopy in whom air insufflation during endoscopy should be used.
Intervention Type
Other
Intervention Name(s)
carbon dioxide insufflation during colonoscopy
Intervention Description
Use of Carbon dioxide instead of air insufflation
Primary Outcome Measure Information:
Title
Comparison of colonoscopy related abdominal pain 1 hour after examination assessed by a visual analogue pain scale in patients with inflammatory bowel disease
Description
For pain assessment a visual analogue scale will be used. For the primary outcome measure, the investigators will compare the difference in pain level 1 hour after colonoscopy (comparison of carbon dioxide to air insufflation).
Time Frame
Pain level assessment 1 hour after colonoscopy
Secondary Outcome Measure Information:
Title
Comparison of colonoscopy related abdominal pain 3 hours, 6 hours and 24 hours after examination assessed by a visual analogue pain scale in patients with inflammatory bowel disease
Description
For pain assessment a visual analogue scale will be used. For the secondary outcome measure, the investigators will compare the differences in pain level 3 hours, 6 hours and 24 hours after colonoscopy (comparison of carbon dioxide to air insufflation).
Time Frame
Pain level assessment 3 hours, 6 hours and 24 hours colonoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with inflammatory bowel disease Indication for colonoscopy Age 18-80 years signed consent form Exclusion Criteria: Consent form not signed Age < 18 or above 80 yrs Pregnancy or Breast-Feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frank Lenze, MD
Phone
0049-251-8358103
Email
frank.lenze@uni-muenster.de
First Name & Middle Initial & Last Name or Official Title & Degree
Arne Bokemeyer, MD
Phone
0049-251-8347661
Email
arne.bokemeyer@ukmuenster.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Lenze, MD
Organizational Affiliation
Department of Medicine B, University Hospital Muenster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unversity Clinic Muenster
City
Muenster
State/Province
NRW
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Lenze, MD, PhD
Phone
00492518458103
Email
frank.lenze@uni-muenster.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease

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