Water-aided Colonoscopy in Inflammatory Bowel Disease Patients
Water-aided Colonoscopy in Patients With Inflammatory Bowel Disease - a Single-center, Single-blinded Randomized Trial
1 other identifier
interventional
92
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedFirst Posted
Study publicly available on registry
September 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedNovember 18, 2014
June 1, 2014
11 months
August 28, 2013
November 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Discomfort during colonoscopy
at the end of each colonoscopy
Cecal intubation time
while reaching the cecum
Study Arms (2)
Water immersion colonoscopy
EXPERIMENTALWater immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Air insufflation colonoscopy
ACTIVE COMPARATORStandard room air insufflation during both colonoscope insertion and withdrawal.
Interventions
Water immersion means infusion of room temperature water during colonoscope insertion without air insufflation.
Eligibility Criteria
You may qualify if:
- known diagnosis of inflammatory bowel disease
- planned diagnostic outpatient colonoscopy
- signed informed consent
- willingness to undergo unsedated colonoscopy
You may not qualify if:
- ulcerative proctitis
- bowel resection longer than ileocecal resection
- requirement for sedation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Digestive Diseases Center, Vitkovice Hospital
Ostrava, 703 84, Czechia
Related Publications (1)
Falt P, Smajstrla V, Fojtik P, Urban O, Hill M. Water-Aided Colonoscopy in Inflammatory Bowel Disease Patients-A Randomised, Single-Centre Trial. J Crohns Colitis. 2015 Sep;9(9):720-4. doi: 10.1093/ecco-jcc/jjv093. Epub 2015 Jun 3.
PMID: 26040317DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MUDr. Premysl Falt, Ph.D.
Study Record Dates
First Submitted
August 28, 2013
First Posted
September 2, 2013
Study Start
September 1, 2013
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
November 18, 2014
Record last verified: 2014-06