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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055689
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Hospital Universitario de Canarias
Information provided by (Responsible Party):
Marco Antonio Alvarez Gonzalez, Parc de Salut Mar

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bowel Preparation for Colonoscopy Behavioral: Educational telephone intervention Behavioral: Standard education for colonoscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 657 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Nurse-led Educational Telephone Intervention for Bowel Preparation for Repeat Colonoscopy After Preparation Failure (RepeatPrep Study)
Actual Study Start Date : January 30, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : December 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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
Behavioral: Educational telephone intervention
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
Behavioral: Standard education for colonoscopy
Standard education for bowel preparation at the time of colonoscopy scheduling




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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

  4. 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)

  5. 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)

  6. Boston Bowel Preparation Scale [ Time Frame: At the moment of colonoscopy ]
    Application of the Boston Bowel Preparation Scale to evaluate colonoscopy bowel cleansing

  7. Barcelona Bowel Preparation Scale [ Time Frame: At the momento of colonoscopy ]
    Application of the Barcelona Bowel Preparation Scale to evaluate colonoscopy bowel cleansing



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055689


Locations
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Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08035
Althaia Hospital de Manresa
Manresa, Barcelona, Spain
Consorci Sanitari Terrassa
Terrassa, Barcelona, Spain
Hospital de Viladecans
Viladecans, Barcelona, Spain
Hospital Santos Reyes
Aranda De Duero, Burgos, Spain
Hospital Universitario de Canarias
Tenerife, Canarias, Spain, 38320
Hospital Universtiario de Móstoles
Móstoles, Madrid, Spain
Hospital Del Mar
Barcelona, Spain, 08003
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08035
Hospital Universitario de Burgos
Burgos, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Gregorio Marañón
Madrid, Spain
Hospital Santa Bárbara
Soria, Spain
Hospital Rio Hortega
Valladolid, Spain
Sponsors and Collaborators
Parc de Salut Mar
Hospital Universitario de Canarias
Publications of Results:
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Responsible Party: Marco Antonio Alvarez Gonzalez, Gastroenterologist deputy doctor, MD, PhD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT03055689    
Other Study ID Numbers: REPEATPREP
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marco Antonio Alvarez Gonzalez, Parc de Salut Mar:
Colonoscopy
Educational intervention