- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03055689
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
Status
Completed
Conditions
Intervention / Treatment
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
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Burgos, Spain
- Hospital Universitario de Burgos
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Madrid, Spain
- Hospital 12 de Octubre
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Madrid, Spain
- Hospital Gregorio Marañón
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Soria, Spain
- Hospital Santa Bárbara
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Valladolid, Spain
- Hospital Rio Hortega
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-
Barcelona
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Badalona, Barcelona, Spain, 08035
- Hospital Germans Trias i Pujol
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Manresa, Barcelona, Spain
- Althaia Hospital de Manresa
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Terrassa, Barcelona, Spain
- Consorci Sanitari Terrassa
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Viladecans, Barcelona, Spain
- Hospital de Viladecans
-
-
Burgos
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Aranda De Duero, Burgos, Spain
- Hospital Santos Reyes
-
-
Canarias
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Tenerife, Canarias, Spain, 38320
- Hospital Universitario de Canarias
-
-
Madrid
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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)
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At the moment of colonoscopy
|
Boston Bowel Preparation Scale
Time Frame: At the moment of colonoscopy
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Application of the Boston Bowel Preparation Scale to evaluate colonoscopy bowel cleansing
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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.
Sponsor
Collaborators
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.
General Publications
- 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.
- 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.
- 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.
- 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.
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
Keywords
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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