Back to resultsWater-aided Colonoscopy in Inflammatory Bowel Disease Patients
Primary Purpose
Inflammatory Bowel Disease
Status
Completed
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
Water immersion
Air insufflation insertion
Sponsored by
About this trial
This is an interventional diagnostic trial for Inflammatory Bowel Disease focused on measuring water, colonoscopy, Crohn´s disease, ulcerative colitis
Eligibility Criteria
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
Sites / Locations
- Digestive Diseases Center, Vitkovice Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Water immersion colonoscopy
Air insufflation colonoscopy
Arm Description
Water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Standard room air insufflation during both colonoscope insertion and withdrawal.
Outcomes
Primary Outcome Measures
Success rate of unsedated colonoscopy
Successful unsedated colonoscopy is defined as reaching the cecum by using given insertion technique without administering sedation.
Secondary Outcome Measures
Discomfort during colonoscopy
Discomfort level using visual continuous scale 0-10 (0 = no pain, 10 = worst pain).
Cecal intubation time
Cecal intubation time is defined as time between colonoscope introduction into the anus and reaching the cecum.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01933867
Brief Title
Water-aided Colonoscopy in Inflammatory Bowel Disease Patients
Official Title
Water-aided Colonoscopy in Patients With Inflammatory Bowel Disease - a Single-center, Single-blinded Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vitkovice Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
Keywords
water, colonoscopy, Crohn´s disease, ulcerative colitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Water immersion colonoscopy
Arm Type
Experimental
Arm Description
Water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Arm Title
Air insufflation colonoscopy
Arm Type
Active Comparator
Arm Description
Standard room air insufflation during both colonoscope insertion and withdrawal.
Intervention Type
Procedure
Intervention Name(s)
Water immersion
Intervention Description
Water immersion means infusion of room temperature water during colonoscope insertion without air insufflation.
Intervention Type
Procedure
Intervention Name(s)
Air insufflation insertion
Other Intervention Name(s)
Room air insufflation during colonoscope insertion.
Primary Outcome Measure Information:
Title
Success rate of unsedated colonoscopy
Description
Successful unsedated colonoscopy is defined as reaching the cecum by using given insertion technique without administering sedation.
Time Frame
at the end of each colonoscopy
Secondary Outcome Measure Information:
Title
Discomfort during colonoscopy
Description
Discomfort level using visual continuous scale 0-10 (0 = no pain, 10 = worst pain).
Time Frame
at the end of each colonoscopy
Title
Cecal intubation time
Description
Cecal intubation time is defined as time between colonoscope introduction into the anus and reaching the cecum.
Time Frame
while reaching the cecum
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Digestive Diseases Center, Vitkovice Hospital
City
Ostrava
ZIP/Postal Code
703 84
Country
Czech Republic
12. IPD Sharing Statement
Citations:
PubMed Identifier
26040317
Citation
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.
Results Reference
derived
Learn more about this trial
Water-aided Colonoscopy in Inflammatory Bowel Disease Patients
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