Water-aided Colonoscopy in Inflammatory Bowel Disease Patients

November 16, 2014 updated by: Premysl Falt MD, Vitkovice Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Ostrava, Czech Republic, 703 84
        • Digestive Diseases Center, Vìtkovice Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • Room air insufflation during colonoscope insertion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at the end of each colonoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
at the end of each colonoscopy
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.
while reaching the cecum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vitkovice Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

August 28, 2013

First Submitted That Met QC Criteria

August 30, 2013

First Posted (Estimate)

September 2, 2013

Study Record Updates

Last Update Posted (Estimate)

November 18, 2014

Last Update Submitted That Met QC Criteria

November 16, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DDC VN 06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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