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NCT02956057 Clinical Trial

Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy

Colonoscopy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02956057
Other study ID # BN102016
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 12, 2016
Est. completion date August 17, 2017

Study information
Verified date October 2020
Source Tomas Bata Hospital, Czech Republic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 1044
Est. completion date August 17, 2017
Est. primary completion date May 29, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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 - history of prior colonic or rectal surgery - inability to obtain valid data from subject

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Polyethylene Glycols

• Natrium picosulfate / Magnesium citrate

• Polyethylene glycol / Ascorbic acid

Locations
Country Name City State
Czechia Faculty Hospital Kralovske Vinohrady Prague

Sponsors (3)
Lead Sponsor Collaborator
Tomas Bata Hospital, Czech Republic Brno University Hospital, Faculty Hospital Kralovske Vinohrady

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

Kojecky V, Matous J, Keil R, Dastych M, Kroupa R, Zadorova Z, Varga M, Dolina J, Kment M, Hep A. A head-to-head comparison of 4-L polyethylene glycol and low-volume solutions before colonoscopy: which is the best? A multicentre, randomized trial. Int J Colorectal Dis. 2017 Dec;32(12):1763-1766. doi: 10.1007/s00384-017-2901-x. Epub 2017 Sep 24. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2) Bowel preparation score 1+2 expressed on Aronchick scale (1 the best, 5 the worst) One day
Secondary Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2) Tolerance of Bowel Preparation Assessed by VAS score 1+2 ( 1-excellent, 5-very poor) One day
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