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

NCT ID: NCT03055689

Last Updated: 2019-04-26

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

NA

Total Enrollment

657 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-30

Study Completion Date

2018-12-25

Brief Summary

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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.

Detailed Description

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Conditions

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Bowel Preparation for Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Educational telephone intervention

This group will receive a nurse-led educational telephone intervention for bowel preparation 24-48 before the colonoscopy

Group Type EXPERIMENTAL

Educational telephone intervention

Intervention Type BEHAVIORAL

Subjects will receive a nurse-led educational telephone intervention for bowel preparation 24-48 hours before the colonoscopy

Standard education for colonoscopy

The control group will receive standard education for bowel preparation at the time of colonoscopy scheduling

Group Type ACTIVE_COMPARATOR

Standard education for colonoscopy

Intervention Type BEHAVIORAL

Standard education for bowel preparation at the time of colonoscopy scheduling

Interventions

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Educational telephone intervention

Subjects will receive a nurse-led educational telephone intervention for bowel preparation 24-48 hours before the colonoscopy

Intervention Type BEHAVIORAL

Standard education for colonoscopy

Standard education for bowel preparation at the time of colonoscopy scheduling

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario de Canarias

OTHER

Sponsor Role collaborator

Parc de Salut Mar

OTHER

Sponsor Role lead

Responsible Party

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Marco Antonio Alvarez Gonzalez

Gastroenterologist deputy doctor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status

Althaia Hospital de Manresa

Manresa, Barcelona, Spain

Site Status

Consorci Sanitari Terrassa

Terrassa, Barcelona, Spain

Site Status

Hospital de Viladecans

Viladecans, Barcelona, Spain

Site Status

Hospital Santos Reyes

Aranda de Duero, Burgos, Spain

Site Status

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Canary Islands, Spain

Site Status

Hospital Universtiario de Móstoles

Móstoles, Madrid, Spain

Site Status

Hospital Del Mar

Barcelona, , Spain

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Hospital Universitario de Burgos

Burgos, , Spain

Site Status

Hospital 12 de Octubre

Madrid, , Spain

Site Status

Hospital Gregorio Marañón

Madrid, , Spain

Site Status

Hospital Santa Bárbara

Soria, , Spain

Site Status

Hospital Rio Hortega

Valladolid, , Spain

Site Status

Countries

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Spain

References

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Alvarez-Gonzalez MA, Flores-Le Roux JA, Seoane A, Pedro-Botet J, Carot L, Fernandez-Clotet A, Raga A, Pantaleon MA, Barranco L, Bory F, Lorenzo-Zuniga V. Efficacy of a multifactorial strategy for bowel preparation in diabetic patients undergoing colonoscopy: a randomized trial. Endoscopy. 2016 Nov;48(11):1003-1009. doi: 10.1055/s-0042-111320. Epub 2016 Aug 4.

Reference Type RESULT
PMID: 27490086 (View on PubMed)

Ness RM, Manam R, Hoen H, Chalasani N. Predictors of inadequate bowel preparation for colonoscopy. Am J Gastroenterol. 2001 Jun;96(6):1797-802. doi: 10.1111/j.1572-0241.2001.03874.x.

Reference Type RESULT
PMID: 11419832 (View on PubMed)

Ibanez M, Parra-Blanco A, Zaballa P, Jimenez A, Fernandez-Velazquez R, Fernandez-Sordo JO, Gonzalez-Bernardo O, Rodrigo L. Usefulness of an intensive bowel cleansing strategy for repeat colonoscopy after preparation failure. Dis Colon Rectum. 2011 Dec;54(12):1578-84. doi: 10.1097/DCR.0b013e31823434c8.

Reference Type RESULT
PMID: 22067188 (View on PubMed)

Liu X, Luo H, Zhang L, Leung FW, Liu Z, Wang X, Huang R, Hui N, Wu K, Fan D, Pan Y, Guo X. Telephone-based re-education on the day before colonoscopy improves the quality of bowel preparation and the polyp detection rate: a prospective, colonoscopist-blinded, randomised, controlled study. Gut. 2014 Jan;63(1):125-30. doi: 10.1136/gutjnl-2012-304292. Epub 2013 Mar 16.

Reference Type RESULT
PMID: 23503044 (View on PubMed)

Other Identifiers

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REPEATPREP

Identifier Type: -

Identifier Source: org_study_id

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