Water-aided Colonoscopy in Inflammatory Bowel Disease Patients

Not Applicable

Completed

• Conditions: Inflammatory Bowel Disease
• Interventions: Procedure: Air insufflation insertion; Procedure: Water immersion

• Registration Number: NCT01933867
• Lead Sponsor: Vitkovice Hospital

Brief Summary

Water-aided insertion of the colonoscope has been repeatedly proven to beneficial in terms of lower discomfort and need for sedation during colonoscopy. Patients with inflammatory bowel diseases (IBD) undergo repeated colonoscopy in course of their disease. According to our preliminary experience, water immersion could be beneficial while scoping these patients. As far as the investigators know, water-aided colonoscopy has never been studied in this indication. Results of our trial might support use of water-aided colonoscopy in common practice and decrease associated discomfort in IBD patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-28
• Study First Submitted QC: 2013-08-30
• Study Start: 2013-09
• Study First Posted: 2013-09-02
• Status Verified: 2014-06
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Last Update Submitted: 2014-11-16
• Last Update Posted: 2014-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• known diagnosis of inflammatory bowel disease
• planned diagnostic outpatient colonoscopy
• signed informed consent
• willingness to undergo unsedated colonoscopy

Exclusion Criteria

• ulcerative proctitis
• bowel resection longer than ileocecal resection
• requirement for sedation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Air insufflation colonoscopy	Air insufflation insertion	Standard room air insufflation during both colonoscope insertion and withdrawal.
Water immersion colonoscopy	Water immersion	Water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.

Primary Outcome Measures

Name	Time	Method
Success rate of unsedated colonoscopy	at the end of each colonoscopy	Successful unsedated colonoscopy is defined as reaching the cecum by using given insertion technique without administering sedation.

Secondary Outcome Measures

Name	Time	Method
Discomfort during colonoscopy	at the end of each colonoscopy	Discomfort level using visual continuous scale 0-10 (0 = no pain, 10 = worst pain).
Cecal intubation time	while reaching the cecum	Cecal intubation time is defined as time between colonoscope introduction into the anus and reaching the cecum.

Trial Locations

Locations (1)

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