Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy

Phase 4

Completed

• Conditions: Colonoscopy
• Interventions: Drug: Natrium picosulfate / Magnesium citrate; Drug: Polyethylene Glycols; Drug: Polyethylene glycol / Ascorbic acid

• Registration Number: NCT02956057
• Lead Sponsor: Tomas Bata Hospital, Czech Republic

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-11-01
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-04
• Study Start: 2016-11-12
• Primary Completion: 2017-05-29
• Study Completion: 2017-08-17
• Results First Submitted: 2019-10-06
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-06
• Last Update Submitted: 2020-10-06
• Results First Posted: 2020-10-28
• Last Update Posted: 2020-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1044

Inclusion Criteria

• Subjects referred to diagnostic or therapeutic colonoscopy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2)	One day	Bowel preparation score 1+2 expressed on Aronchick scale (1 the best, 5 the worst)

Secondary Outcome Measures

Name	Time	Method
Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2)	One day	Tolerance of Bowel Preparation Assessed by VAS score 1+2 ( 1-excellent, 5-very poor)

Trial Locations

Locations (1)

Faculty Hospital Kralovske Vinohrady; 🇨🇿 Prague, Czechia