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

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.

Study Overview

• Status: Unknown
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Other: carbon dioxide insufflation during colonoscopy

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: Interventional
• Enrollment (Anticipated): 304
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frank Lenze, MD; Phone Number: 0049-251-8358103; Email: frank.lenze@uni-muenster.de
• Study Contact Backup: Name: Arne Bokemeyer, MD; Phone Number: 0049-251-8347661; Email: arne.bokemeyer@ukmuenster.de

Study Locations

• Germany
  • NRW
    • Muenster, NRW, Germany, 48149
      • Recruiting
      • Unversity Clinic Muenster
      • Contact: Frank Lenze, MD, PhD; Phone Number: 00492518458103; Email: frank.lenze@uni-muenster.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: carbon dioxide insufflation during colonoscopy; Use of Carbon dioxide instead of air insufflation
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.	Other: carbon dioxide insufflation during colonoscopy; Use of Carbon dioxide instead of air insufflation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Pain level assessment 1 hour after colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Pain level assessment 3 hours, 6 hours and 24 hours colonoscopy

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Investigators: Principal Investigator: Frank Lenze, MD, Department of Medicine B, University Hospital Muenster

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2017
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): January 31, 2022

Study Registration Dates

• First Submitted: September 5, 2017
• First Submitted That Met QC Criteria: September 13, 2017
• First Posted (Actual): September 14, 2017

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 15, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Inflammatory Bowel Disease; Colonoscopy; Crohn's Disease; Carbon Dioxide (CO2)
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: 2017-191-f-S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No