Individualized Bowel Preparation for Colonoscopy (PREP2TARGET)

January 30, 2019 updated by: dr. Theodor Alexandru Voiosu, Clinical Hospital Colentina

A Randomized Clinical Trial Comparing Standard and Invidualized Bowel Preparation for Colonoscopy

A randomized control trial comparing a standard bowel preparation for colonoscopy with an individualized bowel preparation strategy based on patient characteristics

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania, 020125
        • Recruiting
        • Colentina Clinical Hospital
      • Bucharest, Romania
        • Recruiting
        • Carol Davila Emergency Military Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective out-patient diagnostic or therapeutic colonoscopy

Exclusion Criteria:

  • pregnant women; refusal to participate; significant comorbidities (ASA score 3 or above); suspicion of bowel perforation;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: standard group
standard polyethylene glycol preparation for colonoscopy
Drug: Standard Preparation
standard PEG-based bowel preparation for colonoscopy (either split dose 4L polyethylene glycol or split 2L PEG + ascorbic acid)
EXPERIMENTAL: individualized group
either a low or a high volume bowel preparation according to patient characteristics
Drug: Individualized Preparation
individualized bowel preparation for colonoscopy (either split dose 4L PEG or split 2L PEG + ascorbic acid) based o patient characteristics (history of failed bowel preparation; use of laxative drugs, increased BMI, age>65, neurologic comorbidities)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bowel preparation quality
Time Frame: 1-2 hours after completing bowel preparation
Boston bowel preparation score (BBPS)
1-2 hours after completing bowel preparation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient comfort during bowel preparation
Time Frame: 1-2 hours after completing bowel preparation
0-10 patient comfort score using a standard visual-analogue scale
1-2 hours after completing bowel preparation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Hospital Colentina

Investigators

  • Principal Investigator: Theodor Voiosu, Clinical Hospital Colentina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2018

Primary Completion (ANTICIPATED)

November 1, 2019

Study Completion (ANTICIPATED)

November 1, 2019

Study Registration Dates

First Submitted

February 5, 2018

First Submitted That Met QC Criteria

February 5, 2018

First Posted (ACTUAL)

February 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COL-GASTRO-6

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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