Bowel Preparation for Repeat Colonoscopy After Preparation Failure (RepeatPrep Study)

April 25, 2019 updated by: Marco Antonio Alvarez Gonzalez, Parc de Salut Mar

Nurse-led Educational Telephone Intervention for Bowel Preparation for Repeat Colonoscopy After Preparation Failure (RepeatPrep Study)

This trial will evaluate the efficacy in colon cleansing of a nurse-led educational telephone intervention 24-48 hours before a colonoscopy, in selected participants with a previous inadequate bowel preparation.

Study Overview

Study Type

Interventional

Enrollment (Actual)

657

Phase

  • Not Applicable

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

      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08035
        • Hospital de la Santa Creu i Sant Pau
      • Burgos, Spain
        • Hospital Universitario de Burgos
      • Madrid, Spain
        • Hospital 12 de Octubre
      • Madrid, Spain
        • Hospital Gregorio Marañón
      • Soria, Spain
        • Hospital Santa Bárbara
      • Valladolid, Spain
        • Hospital Rio Hortega
    • Barcelona
      • Badalona, Barcelona, Spain, 08035
        • Hospital Germans Trias i Pujol
      • Manresa, Barcelona, Spain
        • Althaia Hospital de Manresa
      • Terrassa, Barcelona, Spain
        • Consorci Sanitari Terrassa
      • Viladecans, Barcelona, Spain
        • Hospital de Viladecans
    • Burgos
      • Aranda De Duero, Burgos, Spain
        • Hospital Santos Reyes
    • Canarias
      • Tenerife, Canarias, Spain, 38320
        • Hospital Universitario de Canarias
    • Madrid
      • Móstoles, Madrid, Spain
        • Hospital Universtiario de Móstoles

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Consecutive patients with a colonoscopy with inadequate bowel preparation, for any indication and where the endoscopist considers that the colonoscopy should be repeated to optimize the visualization with a better bowel preparation. Participants must have been properly informed and they have to sign the inform consent.

Exclusion Criteria:

  • Hospitalized patients
  • Unwillingness to participate in the study
  • Inability to follow instructions: cognitive impairment or language barrier
  • Inability to use a telephone or not owning a telephone
  • Active inflammatory bowel disease
  • Severe renal impairment
  • Pregnancy of breast feeding

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Educational telephone intervention
This group will receive a nurse-led educational telephone intervention for bowel preparation 24-48 before the colonoscopy
Subjects will receive a nurse-led educational telephone intervention for bowel preparation 24-48 hours before the colonoscopy
Active Comparator: Standard education for colonoscopy
The control group will receive standard education for bowel preparation at the time of colonoscopy scheduling
Standard education for bowel preparation at the time of colonoscopy scheduling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adequate bowel cleansing for colonoscopy
Time Frame: At the moment of colonoscopy
The efficacy of bowel preparation will be rated by blinded endoscopists using the Boston Bowel Preparation Scale (BBPS). Adequate bowel cleansing will be defined as a BBPS of 2 or more points in every segment of the colon and inadequate bowel cleansing will be defined by at least one of the colon segments with less than 2 points.
At the moment of colonoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall adenoma detection rate, as defined by the ratio of patients with at least one adenoma in the overall colon
Time Frame: At the moment of colonoscopy
The ratio of patients with at least one adenoma in the overall colon
At the moment of colonoscopy
Adenoma detection rate in the right colon
Time Frame: At the moment of colonoscopy
Ratio of patients with at least one adenoma in the right colon (proximal to the splenic flexure)
At the moment of colonoscopy
Overall serrated lesion detection rate
Time Frame: At the moment of colonoscopy
Ratio of patients with at least one serrated lesion in the overall colon
At the moment of colonoscopy
Serrated lesion detection rate in the right colon
Time Frame: At the moment of colonoscopy
Ratio of patients with at least one serrated lesion in the right colon (proximal to the splenic flexure)
At the moment of colonoscopy
Complete colonoscopy rate
Time Frame: At the moment of colonoscopy
Ratio of successful complete colonoscopies (cecal intubation or in case of previous surgery, ileocolic anastomosis)
At the moment of colonoscopy
Boston Bowel Preparation Scale
Time Frame: At the moment of colonoscopy
Application of the Boston Bowel Preparation Scale to evaluate colonoscopy bowel cleansing
At the moment of colonoscopy
Barcelona Bowel Preparation Scale
Time Frame: At the momento of colonoscopy
Application of the Barcelona Bowel Preparation Scale to evaluate colonoscopy bowel cleansing
At the momento of colonoscopy

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

January 30, 2017

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

December 25, 2018

Study Registration Dates

First Submitted

February 14, 2017

First Submitted That Met QC Criteria

February 14, 2017

First Posted (Actual)

February 16, 2017

Study Record Updates

Last Update Posted (Actual)

April 26, 2019

Last Update Submitted That Met QC Criteria

April 25, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • REPEATPREP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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