Water-aided Colonoscopy in Inflammatory Bowel Disease Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Vitkovice Hospital
Sponsor:
Information provided by (Responsible Party):
Premysl Falt MD, Vitkovice Hospital
ClinicalTrials.gov Identifier:
NCT01933867
First received: August 28, 2013
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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 Intervention
Inflammatory Bowel Disease
Procedure: Water immersion
Procedure: Air insufflation insertion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Water-aided Colonoscopy in Patients With Inflammatory Bowel Disease - a Single-center, Single-blinded Randomized Trial

Resource links provided by NLM:


Further study details as provided by Vitkovice Hospital:

Primary Outcome Measures:
  • Success rate of unsedated colonoscopy [ Time Frame: at the end of each colonoscopy ] [ Designated as safety issue: No ]
    Successful unsedated colonoscopy is defined as reaching the cecum by using given insertion technique without administering sedation.


Secondary Outcome Measures:
  • Discomfort during colonoscopy [ Time Frame: at the end of each colonoscopy ] [ Designated as safety issue: No ]
    Discomfort level using visual continuous scale 0-10 (0 = no pain, 10 = worst pain).

  • Cecal intubation time [ Time Frame: while reaching the cecum ] [ Designated as safety issue: No ]
    Cecal intubation time is defined as time between colonoscope introduction into the anus and reaching the cecum.


Estimated Enrollment: 96
Study Start Date: September 2013
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01933867

Contacts
Contact: Premysl Falt, M.D., Ph.D. +420602689561 faltprem@centrum.cz
Contact: Vit Smajstrla, M.D. bormed1@volny.cz

Locations
Czech Republic
Digestive Diseases Center, Vitkovice Hospital Recruiting
Ostrava, Czech Republic, 703 84
Contact: Premysl Falt, M.D., Ph.D.    +420602689561    faltprem@centrum.cz   
Principal Investigator: Premysl Falt, M.D.         
Sponsors and Collaborators
Vitkovice Hospital
  More Information

No publications provided

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
Study First Received: August 28, 2013
Last Updated: June 26, 2014
Health Authority: Czech Republic: Ethics Committee

Keywords provided by Vitkovice Hospital:
water
colonoscopy
Crohn´s disease
ulcerative colitis

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

ClinicalTrials.gov processed this record on October 23, 2014