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NCT02908919 Clinical Trial

Impact of Time Intervals of Preparation on Quality and Tolerance of the Bowel Preparation

Colonoscopy Clinical Trial

Official title:
Impact of Time Intervals on Quality and Tolerance of the Bowel Preparation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02908919
Other study ID # CB1601
Secondary ID
Status Recruiting
Phase Phase 4
First received September 9, 2016
Last updated November 1, 2016
Start date August 2016
Est. completion date December 2016

Study information
Verified date November 2016
Source Faculty Hospital Kralovske Vinohrady
Contact Jan Matous, MD
Phone +420267163680
Email jan.matous1@fnkv.cz
Is FDA regulated No
Health authority Czech Republic: State Institute for Drug Control
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine optimal time intervals for preparation before colonoscopy using different formulas.

Description:

Different formulas are used for bowel preparation before colonoscopy. Present guidelines are based on conventional polyethylene glycol. Their validity for other preparations were not evaluated. Relationship between length of preparation, interval to colonoscopy and bowel preparation quality, tolerance are assessed.

Recruitment information / eligibility
Status Recruiting
Enrollment 480
Est. completion date December 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- subjects referred to diagnostic or therapeutic colonoscopy.

Exclusion Criteria:

- ileus

- known or suspected bowel obstruction

- active bowel inflammation

- pregnancy

- any presence of serious medical conditions ( esp. cardiac, renal, liver diseases)

- history of prior colonic or rectal surgery

- inability to obtain valid data from

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Colonoscopy
The quality of bowel preparation, which is checked during colonoscopy

Locations
Country Name City State
Czech Republic Faculty Hospital Kralovske Vinohrady Prague
Czech Republic Nemocnice T.Bati Zlin

Sponsors (4)
Lead Sponsor Collaborator
Faculty Hospital Kralovske Vinohrady Brno University Hospital, Nemocnice T.Bati, Zlin, University Hospital, Motol

Country where clinical trial is conducted

Czech Republic, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of bowel preparation according to time intervals of bowel preparation The length of bowel preparation and interval to colonoscopy for bowel preparation quality Aronchick score excellent and good One day No
Secondary Tolerance of bowel preparation according to time intervals of bowel preparation One day No
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