Water-aided Colonoscopy in Inflammatory Bowel Disease Patients

Inflammatory Bowel Disease Clinical Trial

Official title:

Water-aided Colonoscopy in Patients With Inflammatory Bowel Disease - a Single-center, Single-blinded Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933867
• Other study ID #: DDC VN 06
• Status: Completed
• Phase: N/A
• First received: August 28, 2013
• Last updated: November 16, 2014
• Start date: September 2013
• Est. completion date: August 2014

Study information

• Verified date: June 2014
• Source: Vitkovice Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Procedure:
• Water immersion
Water immersion means infusion of room temperature water during colonoscope insertion without air insufflation.
• Air insufflation insertion

Locations

Country	Name	City	State
Czech Republic	Digestive Diseases Center, Vitkovice Hospital	Ostrava

Sponsors (1)

Lead Sponsor	Collaborator
Vitkovice Hospital

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of unsedated colonoscopy	Successful unsedated colonoscopy is defined as reaching the cecum by using given insertion technique without administering sedation.	at the end of each colonoscopy	No
Secondary	Discomfort during colonoscopy	Discomfort level using visual continuous scale 0-10 (0 = no pain, 10 = worst pain).	at the end of each colonoscopy	No
Secondary	Cecal intubation time	Cecal intubation time is defined as time between colonoscope introduction into the anus and reaching the cecum.	while reaching the cecum	No