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Water-aided Colonoscopy in Inflammatory Bowel Disease Patients

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ClinicalTrials.gov Identifier: NCT01933867
Recruitment Status : Completed
First Posted : September 2, 2013
Last Update Posted : November 18, 2014
Sponsor:
Information provided by (Responsible Party):
Premysl Falt MD, 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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Procedure: Water immersion Procedure: Air insufflation insertion Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Water-aided Colonoscopy in Patients With Inflammatory Bowel Disease - a Single-center, Single-blinded Randomized Trial
Study Start Date : September 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Water immersion colonoscopy
Water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
Procedure: Water immersion
Water immersion means infusion of room temperature water during colonoscope insertion without air insufflation.

Active Comparator: Air insufflation colonoscopy
Standard room air insufflation during both colonoscope insertion and withdrawal.
Procedure: Air insufflation insertion
Other Name: Room air insufflation during colonoscope insertion.




Primary Outcome Measures :
  1. Success rate of unsedated colonoscopy [ Time Frame: 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 :
  1. Discomfort during colonoscopy [ Time Frame: at the end of each colonoscopy ]
    Discomfort level using visual continuous scale 0-10 (0 = no pain, 10 = worst pain).

  2. Cecal intubation time [ Time Frame: while reaching the cecum ]
    Cecal intubation time is defined as time between colonoscope introduction into the anus and reaching the cecum.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933867


Locations
Czech Republic
Digestive Diseases Center, Vitkovice Hospital
Ostrava, Czech Republic, 703 84
Sponsors and Collaborators
Vitkovice Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Premysl Falt MD, MUDr. Premysl Falt, Ph.D., Vitkovice Hospital
ClinicalTrials.gov Identifier: NCT01933867     History of Changes
Other Study ID Numbers: DDC VN 06
First Posted: September 2, 2013    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: June 2014

Keywords provided by Premysl Falt MD, Vitkovice Hospital:
water
colonoscopy
Crohn´s disease
ulcerative colitis

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis