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

Bowel Preparation for Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055689
• Other study ID #: REPEATPREP
• Status: Completed
• Phase: N/A
• Start date: January 30, 2017
• Est. completion date: December 25, 2018

Study information

• Verified date: April 2019
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 657
• Est. completion date: December 25, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Bowel Preparation for Colonoscopy

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Santos Reyes	Aranda De Duero	Burgos
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Del Mar	Barcelona
Spain	Hospital Universitario de Burgos	Burgos
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Althaia Hospital de Manresa	Manresa	Barcelona
Spain	Hospital Universtiario de Móstoles	Móstoles	Madrid
Spain	Hospital Santa Bárbara	Soria
Spain	Hospital Universitario de Canarias	Tenerife	Canarias
Spain	Consorci Sanitari Terrassa	Terrassa	Barcelona
Spain	Hospital Rio Hortega	Valladolid
Spain	Hospital de Viladecans	Viladecans	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Parc de Salut Mar	Hospital Universitario de Canarias

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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-Zuñiga V. Efficacy of a multifactorial strategy for bowel preparation in diabetic patients undergoing colonosco — View Citation

Ibáñez M, Parra-Blanco A, Zaballa P, Jiménez A, Fernández-Velázquez R, Fernández-Sordo JO, González-Bernardo O, Rodrigo L. Usefulness of an intensive bowel cleansing strategy for repeat colonoscopy after preparation failure. Dis Colon Rectum. 2011 Dec;54( — View Citation

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-blin — View Citation

Ness RM, Manam R, Hoen H, Chalasani N. Predictors of inadequate bowel preparation for colonoscopy. Am J Gastroenterol. 2001 Jun;96(6):1797-802. — View Citation

Outcome

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