Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy

October 6, 2020 updated by: Vladimir Kojecky, MD, Ph.D., Tomas Bata Hospital, Czech Republic

A Head-to-head Comparison of Efficiency and Tolerance of 4-L Polyethylene Glycol and Sodium Picosulphate/ Magnesium Citrate, Polyethylene Glycol/Ascorbate Before Colonoscopy

Study evaluates the efficacy and tolerability of low volume preparations compared with conventional 4L polyethylene glycol prior to colonoscopy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To compare the efficacy and tolerance of standard polyethylene glycol to low volume sodium picosulphate/magnesium citrate and polyethylene glycol/ascorbic acid in a single or split dose regimen for colonoscopy bowel preparation in a head-to-head design.

Study Type

Interventional

Enrollment (Actual)

1044

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

  • Czechia
      • Prague, Czechia, 10024
        • Faculty Hospital Kralovske Vinohrady

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:

  • 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
  • history of prior colonic or rectal surgery
  • inability to obtain valid data from subject

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: PEG1D
Polyethylene glycols single dose a day before colonoscopy
Drug: Polyethylene Glycols
ACTIVE_COMPARATOR: PEG2D
Polyethylene glycols split dose
Drug: Polyethylene Glycols
ACTIVE_COMPARATOR: SPMC1D
Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy
Drug: Natrium picosulfate / Magnesium citrate
ACTIVE_COMPARATOR: SPMC2D
Natrium picosulfate/ Magnesium citrate split dose
Drug: Natrium picosulfate / Magnesium citrate
ACTIVE_COMPARATOR: PEGA1D
Polyethylene glycol / Ascorbic acid single dose day before colonoscopy
Drug: Polyethylene glycol / Ascorbic acid
ACTIVE_COMPARATOR: PEGA2D
Polyethylene glycol / Ascorbic acid split dose
Drug: Polyethylene glycol / Ascorbic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2)
Time Frame: One day
Bowel preparation score 1+2 expressed on Aronchick scale (1 the best, 5 the worst)
One day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2)
Time Frame: One day
Tolerance of Bowel Preparation Assessed by VAS score 1+2 ( 1-excellent, 5-very poor)
One day

Collaborators and Investigators

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

Sponsor

Tomas Bata Hospital, Czech Republic

Collaborators

Brno University Hospital
Faculty Hospital Kralovske Vinohrady

Investigators

  • Principal Investigator: Vladimir Kojecky, MD, Nemocnice T.Bati

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 (ACTUAL)

November 12, 2016

Primary Completion (ACTUAL)

May 29, 2017

Study Completion (ACTUAL)

August 17, 2017

Study Registration Dates

First Submitted

November 1, 2016

First Submitted That Met QC Criteria

November 3, 2016

First Posted (ESTIMATE)

November 4, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 28, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BN102016

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.

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