A Multicenter Single-blind Comparison Between Standard and Individualized Approach in Bowel Preparation Before Colonoscopy

A Comparison of Bowel Prep Quality and Patient Satisfaction in Outpatients Undergoing Colonoscopy Preparation With Either a Standard Bowel Preparation or an Individualized Approach Using Sodium Picosulphatge/Magnesium Citrate or 4L Polyethylene Glycol Preparation Regimens

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02024022

Enrollment

185

Registered

2013-12-31

Start date

2014-02-28

Completion date

2015-12-31

Last updated

2016-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Cleansing Process, Colonoscopy

Keywords

colonoscopy, bowel cleansing, polyethylene glycol, sodium picosulphate / magnesium citrate

Brief summary

This study aims to compare a standard approach to bowel preparation for colonoscopy (using sodium picosulphate/magnesium citrate or 4lPEG) to an individualized approach where patients are assigned a specific regimen of either sodium picosulphate/magnesium citrate or 4lPEG depending on patient-related factors. The study aims to compare patient-related outcomes such as comfort levels during bowel cleansing and physician-related outcomes such as bowel prep quality in the two study groups.

Interventions

DRUGStandard approach

bowel cleansing with either 4L PEG or sodium picosulphate/magnesium citrate

DRUGIndividualized approach

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* all patients \> 18 years of age undergoing elective colonoscopy on an outpatient basis

Exclusion criteria

* refusal to sign informed consent * pregnancy * advance kidney, liver or heart disease * suspicion of malignant / benign stenosis of the digestive tract

Design outcomes

Primary

Measure	Time frame	Description
bowel cleansing	24 hours	bowel cleansing as assessed during colonoscopy using 2 assessment scales (Boston bowel prep scale, and a 1-4 semiquantitative scale)

Secondary

Measure	Time frame	Description
patient comfort level during bowel cleansing	24 hours	patient pain levels on a 0-10 visual analogue scale during the bowel cleansing process

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026