Carbon Dioxide Insufflation Colonoscopy in IBD Patients

Not Applicable

Completed

• Conditions: Carbon Dioxide; Inflammatory Bowel Disease; Colonoscopy
• Interventions: Procedure: Carbon dioxide insufflation

• Registration Number: NCT02563132
• Lead Sponsor: Vitkovice Hospital

Brief Summary

Carbon dioxide insufflation during colonoscopy significantly reduces discomfort (pain, bloating and flatulence) after the procedure. So far, it has not been studied in inflammatory bowel disease patients. The study was designed to evaluate discomfort after the carbon dioxide insufflation colonoscopy in comparison to standard air insufflation colonoscopy.

Detailed Description

Carbon dioxide insufflation during colonoscopy significantly reduces discomfort (pain, bloating and flatulence) during up to 24 hours after the procedure. So far, it has not been studied in inflammatory bowel disease patients who represent specific patient population indicated for colonoscopy. They are characterized by younger age, structural changes of the colon including intestinal resections and need for repeated and frequently difficult procedures.The study was designed to evaluate discomfort during 24 hours after the carbon dioxide insufflation colonoscopy in comparison to standard air insufflation colonoscopy.

Study Timeline

• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-29
• Study Start: 2015-10
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-28
• Last Update Posted: 2016-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• known diagnosis of Crohn´s disease and ulcerative colitis
• indication for diagnostic colonoscopy
• informed consent
• unsedated or minimally sedated procedure (< 3 mg of midazolam)

Exclusion Criteria

• planned incomplete or therapeutic procedure
• deep sedation or general anesthesia
• intestinal resection longer than ileocecal resection
• isolated gastroduodenal or jejunal location of Crohn´s disease (L4)
• ulcerative proctitis (E1)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbon dioxide insufflation colonoscopy (CO2)	Carbon dioxide insufflation	Carbon dioxide during both insertion and withdrawal phase of the colonoscopy.

Primary Outcome Measures

Name	Time	Method
Bloating score 1 hour after the colonoscopy	1 hour	Bloating severity on continuous scale 0-10 (0 = none, 10 = worst) 1 hour after colonoscopy

Trial Locations

Locations (1)

Digestive Diseases Center - Vitkovice Hospital; 🇨🇿 Ostrava, Czech Republic