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Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy

NCT ID: NCT02956057

Last Updated: 2020-10-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1044 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-12

Study Completion Date

2017-08-17

Brief Summary

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

Detailed Description

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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.

Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PEG1D

Polyethylene glycols single dose a day before colonoscopy

Group Type ACTIVE_COMPARATOR

Polyethylene Glycols

Intervention Type DRUG

PEG2D

Polyethylene glycols split dose

Group Type ACTIVE_COMPARATOR

Polyethylene Glycols

Intervention Type DRUG

SPMC1D

Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy

Group Type ACTIVE_COMPARATOR

Natrium picosulfate / Magnesium citrate

Intervention Type DRUG

SPMC2D

Natrium picosulfate/ Magnesium citrate split dose

Group Type ACTIVE_COMPARATOR

Natrium picosulfate / Magnesium citrate

Intervention Type DRUG

PEGA1D

Polyethylene glycol / Ascorbic acid single dose day before colonoscopy

Group Type ACTIVE_COMPARATOR

Polyethylene glycol / Ascorbic acid

Intervention Type DRUG

PEGA2D

Polyethylene glycol / Ascorbic acid split dose

Group Type ACTIVE_COMPARATOR

Polyethylene glycol / Ascorbic acid

Intervention Type DRUG

Interventions

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Polyethylene Glycols

Intervention Type DRUG

Natrium picosulfate / Magnesium citrate

Intervention Type DRUG

Polyethylene glycol / Ascorbic acid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brno University Hospital

OTHER

Sponsor Role collaborator

Faculty Hospital Kralovske Vinohrady

OTHER_GOV

Sponsor Role collaborator

Tomas Bata Hospital, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Vladimir Kojecky, MD, Ph.D.

MUDr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vladimir Kojecky, MD

Role: PRINCIPAL_INVESTIGATOR

Nemocnice T.Bati

Locations

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Faculty Hospital Kralovske Vinohrady

Prague, , Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type BACKGROUND
PMID: 28944412 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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BN102016

Identifier Type: -

Identifier Source: org_study_id