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Completed

NCT Number: NCT03055689

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.

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Key information

Conditions

Bowel Preparation for Colonoscopy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational telephone intervention

Behavioral

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

Standard education for colonoscopy

Behavioral

Standard education for bowel preparation at the time of colonoscopy scheduling

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Collaborators

  • Hospital Universitario de Canarias

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 16, 2017
Registry last updated
Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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