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

NCT03282786 | Unknown

• 1 other identifier: 2017-191-f-S
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Keywords

Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis; Carbon Dioxide (CO2); Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

  Pain level assessment 3 hours, 6 hours and 24 hours colonoscopy

Study Arms (4)

CD patient with CO2 insufflation

ACTIVE COMPARATOR

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

CD patient with air insufflation

NO INTERVENTION

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

UC patient with CO2 insufflation

ACTIVE COMPARATOR

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

UC patient with air insufflation

NO INTERVENTION

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

Interventions

carbon dioxide insufflation during colonoscopy OTHER

Use of Carbon dioxide instead of air insufflation

CD patient with CO2 insufflation; UC patient with CO2 insufflation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

Unversity Clinic Muenster

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Frank Lenze, MD

  Department of Medicine B, University Hospital Muenster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank Lenze, MD

CONTACT

0049-251-8358103; frank.lenze@uni-muenster.de

Arne Bokemeyer, MD

CONTACT

0049-251-8347661; arne.bokemeyer@ukmuenster.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 14, 2017
• Study Start: September 3, 2017
• Primary Completion: August 1, 2021
• Study Completion: January 31, 2022
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

DE (1)