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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bowel Cleansing Process Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard approach

patients will be randomized to one of the 2 currently used bowel preparation regimens in our clinic:

* 4L split polyethylene glycol solution
* split magnesium citrate/sodium picosulphate preparation regimen

Group Type ACTIVE_COMPARATOR

Standard approach

Intervention Type DRUG

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

Individualized approach

patients will receive either the 4L split polyethylene glycol bowel prep regimen or the sodium picosulphate/magnesium citrate split prep regimen according to personal characteristics assessed using a self-administered questionnaire (including bowel habits, the preference for large-volume preparation and education level)

Group Type EXPERIMENTAL

Individualized approach

Intervention Type DRUG

Interventions

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Standard approach

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

Intervention Type DRUG

Individualized approach

Intervention Type DRUG

Other Intervention Names

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4 L polyethylene glycol or sodium picosulphate / magnesium citrate

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No