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

November 1, 2016 updated by: MUDr. Jan Matous, Faculty Hospital Kralovske Vinohrady

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Phase 4

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
      • Prague, Czech Republic, 10024
        • Recruiting
        • Faculty Hospital Kralovske Vinohrady
      • Zlin, Czech Republic, 76275
        • Recruiting
        • Nemocnice T.Bati

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 to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Fortrans pulv. sol
Polyethylene glycol solution. Used 4 l before colonoscopy. Bowel preparation interval: QD/BID or one day.
Procedure: Colonoscopy
The quality of bowel preparation, which is checked during colonoscopy
ACTIVE_COMPARATOR: Picoprep pulv. sol.
Natrium picosulfate/ magnesium citrate solution. Used 2 l before colonoscopy. bowel preparation interval: QD/BID or one day.
Procedure: Colonoscopy
The quality of bowel preparation, which is checked during colonoscopy
ACTIVE_COMPARATOR: Moviprep pulv. sol.
Polyethylene glycol + ascorbic acid solution. Used 2 l before colonoscopy. Bowel preparation interval: QD/BID or one day.
Procedure: Colonoscopy
The quality of bowel preparation, which is checked during colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of bowel preparation according to time intervals of bowel preparation
Time Frame: One day
The length of bowel preparation and interval to colonoscopy for bowel preparation quality Aronchick score excellent and good
One day

Secondary Outcome Measures

Outcome Measure
Time Frame
Tolerance of bowel preparation according to time intervals of bowel preparation
Time Frame: One day
One day

Collaborators and Investigators

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

Sponsor

Faculty Hospital Kralovske Vinohrady

Collaborators

Brno University Hospital
University Hospital, Motol
Nemocnice T.Bati, Zlin

Investigators

  • Principal Investigator: Jan Matous, MD, Faculty Hospital Kralovske Vinohrady, Prague

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

August 1, 2016

Primary Completion (ANTICIPATED)

November 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

September 9, 2016

First Submitted That Met QC Criteria

September 20, 2016

First Posted (ESTIMATE)

September 21, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

November 3, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CB1601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Colonoscopy

Clinical Trials on Colonoscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe