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

Not Applicable

Completed

• Conditions: Bowel Preparation for Colonoscopy

• Registration Number: NCT03055689
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-30
• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-02-14
• Study First Posted: 2017-02-16
• Primary Completion: 2018-06-30
• Study Completion: 2018-12-25
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-25
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 657

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adequate bowel cleansing for colonoscopy	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

Name	Time	Method
Adenoma detection rate in the right colon	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	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	At the moment of colonoscopy	Ratio of patients with at least one serrated lesion in the right colon (proximal to the splenic flexure)
Boston Bowel Preparation Scale	At the moment of colonoscopy	Application of the Boston Bowel Preparation Scale to evaluate colonoscopy bowel cleansing
Barcelona Bowel Preparation Scale	At the momento of colonoscopy	Application of the Barcelona Bowel Preparation Scale to evaluate colonoscopy bowel cleansing
Overall adenoma detection rate, as defined by the ratio of patients with at least one adenoma in the overall colon	At the moment of colonoscopy	The ratio of patients with at least one adenoma in the overall colon
Complete colonoscopy rate	At the moment of colonoscopy	Ratio of successful complete colonoscopies (cecal intubation or in case of previous surgery, ileocolic anastomosis)

Trial Locations

Locations (14)

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

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

Hospital Universtiario de Móstoles; 🇪🇸 Móstoles, Madrid, Spain

Hospital Del Mar; 🇪🇸 Barcelona, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitario de Burgos; 🇪🇸 Burgos, Spain

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