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

Overview

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.

Full Title of Study: “Nurse-led Educational Telephone Intervention for Bowel Preparation for Repeat Colonoscopy After Preparation Failure (RepeatPrep Study)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2018

Interventions

  • Behavioral: Educational telephone intervention
    • Subjects will receive a nurse-led educational telephone intervention for bowel preparation 24-48 hours before the colonoscopy
  • Behavioral: Standard education for colonoscopy
    • Standard education for bowel preparation at the time of colonoscopy scheduling

Arms, Groups and Cohorts

  • Experimental: Educational telephone intervention
    • This group will receive a nurse-led educational telephone intervention for bowel preparation 24-48 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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)
  • 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
  • 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)
  • 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)
  • Boston Bowel Preparation Scale
    • Time Frame: At the moment of colonoscopy
    • Application of the Boston Bowel Preparation Scale to evaluate colonoscopy bowel cleansing
  • Barcelona Bowel Preparation Scale
    • Time Frame: At the momento of colonoscopy
    • Application of the Barcelona Bowel Preparation Scale to evaluate colonoscopy bowel cleansing

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Parc de Salut Mar
  • Collaborator
    • Hospital Universitario de Canarias
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marco Antonio Alvarez Gonzalez, Gastroenterologist deputy doctor, MD, PhD – Parc de Salut Mar

Citations Reporting on Results

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.

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