Trial record 5 of 1686 for: CARBON DIOXIDE AND dioxide

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

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ClinicalTrials.gov Identifier: NCT03282786

Recruitment Status : Recruiting

First Posted : September 14, 2017

Last Update Posted : September 14, 2017

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

University Hospital Muenster

Tracking Information

First Submitted Date ^ICMJE

September 5, 2017

First Posted Date ^ICMJE

September 14, 2017

Last Update Posted Date

September 14, 2017

Actual Study Start Date ^ICMJE

September 3, 2017

Estimated Primary Completion Date

August 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Comparison of colonoscopy related abdominal pain 1 hour after examination assessed by a visual analogue pain scale in patients with inflammatory bowel disease [ Time Frame: Pain level assessment 1 hour after colonoscopy ]

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).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 [ Time Frame: Pain level assessment 3 hours, 6 hours and 24 hours colonoscopy ]

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).

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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).

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic

Condition ^ICMJE

Inflammatory Bowel Diseases

Intervention ^ICMJE

Other: carbon dioxide insufflation during colonoscopy

Use of Carbon dioxide instead of air insufflation

Study Arms ^ICMJE

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

Intervention: Other: carbon dioxide insufflation during colonoscopy
No Intervention: CD patient with air insufflation
The investigators aim to include 76 Crohn's disease patients undergoing colonoscopy in whom air insufflation during endoscopy should be used.
Active Comparator: UC patient with CO2 insufflation
The investigators aim to include 76 ulcerative colitis patients (UC) undergoing colonoscopy in whom CO2 insufflation during endoscopy should be used.

Intervention: Other: carbon dioxide insufflation during colonoscopy
No Intervention: UC patient with air insufflation
The investigators aim to include 76 ulcerative colitis patients undergoing colonoscopy in whom air insufflation during endoscopy should be used.

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

Recruiting

Estimated Enrollment ^ICMJE

304

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

January 31, 2020

Estimated Primary Completion Date

August 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 80 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Frank Lenze, MD	0049-251-8358103	frank.lenze@uni-muenster.de
Contact: Arne Bokemeyer, MD	0049-251-8347661	arne.bokemeyer@ukmuenster.de

Listed Location Countries ^ICMJE

Germany

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT03282786

Other Study ID Numbers ^ICMJE

2017-191-f-S

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

Undecided

Responsible Party

University Hospital Muenster

Study Sponsor ^ICMJE

University Hospital Muenster

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Frank Lenze, MD

Department of Medicine B, University Hospital Muenster

PRS Account

University Hospital Muenster

Verification Date

August 2017

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

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