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

Phase 4

• Conditions: Colonoscopy; Bowel Preparation
• Interventions: Procedure: Colonoscopy

• Registration Number: NCT02908919
• Lead Sponsor: Faculty Hospital Kralovske Vinohrady

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-21
• Status Verified: 2016-11
• Primary Completion: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-03
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 480

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fortrans pulv. sol	Colonoscopy	Polyethylene glycol solution. Used 4 l before colonoscopy. Bowel preparation interval: QD/BID or one day.
Moviprep pulv. sol.	Colonoscopy	Polyethylene glycol + ascorbic acid solution. Used 2 l before colonoscopy. Bowel preparation interval: QD/BID or one day.
Picoprep pulv. sol.	Colonoscopy	Natrium picosulfate/ magnesium citrate solution. Used 2 l before colonoscopy. bowel preparation interval: QD/BID or one day.

Primary Outcome Measures

Name	Time	Method
Quality of bowel preparation according to time intervals of bowel preparation	One day	The length of bowel preparation and interval to colonoscopy for bowel preparation quality Aronchick score excellent and good

Secondary Outcome Measures

Name	Time	Method
Tolerance of bowel preparation according to time intervals of bowel preparation	One day

Trial Locations

Locations (2)

Faculty Hospital Kralovske Vinohrady; 🇨🇿 Prague, Czech Republic

Nemocnice T.Bati; 🇨🇿 Zlin, Czech Republic