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

NCT ID: NCT03282786

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-03
• Study Completion Date: 2022-01-31

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).

Conditions

Inflammatory Bowel Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

carbon dioxide insufflation during colonoscopy

Intervention Type: OTHER

Use of Carbon dioxide instead of air insufflation

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

carbon dioxide insufflation during colonoscopy

Intervention Type: OTHER

Use of Carbon dioxide instead of air insufflation

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

carbon dioxide insufflation during colonoscopy

Use of Carbon dioxide instead of air insufflation

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Muenster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Lenze, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine B, University Hospital Muenster

Locations

Unversity Clinic Muenster

Münster, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Frank Lenze, MD

Role: CONTACT

frank.lenze@uni-muenster.de

0049-251-8358103

Arne Bokemeyer, MD

Role: CONTACT

arne.bokemeyer@ukmuenster.de

0049-251-8347661

Facility Contacts

Frank Lenze, MD, PhD

Role: primary

frank.lenze@uni-muenster.de

00492518458103

Other Identifiers

2017-191-f-S

Identifier Type: -

Identifier Source: org_study_id