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Completed

NCT Number: NCT02024022

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

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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Key information

Conditions

Bowel Cleansing Process Colonoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Colentina Clinical Hospital, Bucharest, Romania

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard approach

Drug

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

Individualized approach

Drug

Other names: 4 L polyethylene glycol or sodium picosulphate / magnesium citrate

Primary outcomes

  1. bowel cleansing

    Time frame: 24 hours

    bowel cleansing as assessed during colonoscopy using 2 assessment scales (Boston bowel prep scale, and a 1-4 semiquantitative scale)

Secondary outcomes

  1. patient comfort level during bowel cleansing

    Time frame: 24 hours

    patient pain levels on a 0-10 visual analogue scale during the bowel cleansing process

Sponsors and collaborators

Lead sponsor

Clinical Hospital Colentina

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 31, 2013
Registry last updated
Jan 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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