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Water-aided Colonoscopy in Inflammatory Bowel Disease Patients

NCT ID: NCT01933867

Last Updated: 2014-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammatory Bowel Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Water immersion colonoscopy

Water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.

Group Type EXPERIMENTAL

Water immersion

Intervention Type PROCEDURE

Water immersion means infusion of room temperature water during colonoscope insertion without air insufflation.

Air insufflation colonoscopy

Standard room air insufflation during both colonoscope insertion and withdrawal.

Group Type ACTIVE_COMPARATOR

Air insufflation insertion

Intervention Type PROCEDURE

Interventions

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Water immersion

Water immersion means infusion of room temperature water during colonoscope insertion without air insufflation.

Intervention Type PROCEDURE

Air insufflation insertion

Intervention Type PROCEDURE

Other Intervention Names

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Room air insufflation during colonoscope insertion.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vitkovice Hospital

OTHER

Sponsor Role lead

Responsible Party

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Premysl Falt MD

MUDr. Premysl Falt, Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Digestive Diseases Center, Vitkovice Hospital

Ostrava, , Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type DERIVED
PMID: 26040317 (View on PubMed)

Other Identifiers

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DDC VN 06

Identifier Type: -

Identifier Source: org_study_id