Comparison of Bowel Cleansing Regimens Prior to Colonoscopy (PRECOL2011-1)

March 23, 2023 updated by: National Cancer Institute, Naples

PRECOL2011-1: Sodium Picophosphate and Magnesium Citrate Versus Polyethylene Glycol as Evacuating Treatment Prior to Colonoscopy: Phase IV Randomized Trial.

The purpose of this study is to to compare two bowel preparation regimens of patients who will undergo colonoscopy, in terms of quality of bowel preparation and in terms of patient satisfaction.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

525

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

  • Italy
      • Marsicovetere, Italy
        • Presidio Ospedaliero Villa d'Agri
      • Milano, Italy
        • AO Fatebenefratelli ed Oftalmico
      • Napoli, Italy
        • Istituto Nazionale dei Tumori
      • Napoli, Italy
        • A.O.U. Seconda Universita di Napoli
      • Napoli, Italy
        • Clinica Mediterranea
      • Napoli, Italy
        • Presidio Ospedaliero Ascalesi
      • Torre del Greco, Italy
        • Presidio Ospedaliero Maresca

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:

• Subjects who are candidate to undergo colonoscopy: Diagnosis Screening Follow-up after previous polypectomy

  • Informed consent
  • Age > 18 years

Exclusion Criteria:

  • Previous colonic resection
  • Severe inflammatory bowel disease (IBD)

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PEG
polyethylene glycol solution 2 liters
Drug: polyethylene glycole (PEG) solution
Active Comparator: NapP
Sodium picosulphate and magnesium citrate solution 300 ml
Drug: sodium picosulphate and magnesium citrate solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Boston Bowel Preparation Scale value
Time Frame: at time of colonscopy
evaluated by two endoscopists who are blinded to treatment assigned at randomization
at time of colonscopy
patient reported acceptability score
Time Frame: just prior to colonscopy
using visual analog scale
just prior to colonscopy

Secondary Outcome Measures

Outcome Measure
Time Frame
percent of bowel cleansing regimen dose assumed as reported by patient
Time Frame: just prior to colonoscopy
just prior to colonoscopy

Collaborators and Investigators

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

Sponsor

National Cancer Institute, Naples

Investigators

  • Principal Investigator: Valentina D'Angelo, M.D., National Cancer Institute, Naples
  • Principal Investigator: Mario de Bellis, M.D., National Cancer Institute, Naples

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

November 1, 2011

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

July 23, 2012

First Submitted That Met QC Criteria

July 24, 2012

First Posted (Estimate)

July 25, 2012

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRECOL2011-1
  • 2011-000587-10 (Registry Identifier: EudraCT)

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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