Clinical trial NCT03055689: Bowel Preparation for Repeat Colonoscopy After Preparation Failure (RepeatPrep Study)
Official title: Nurse-led Educational Telephone Intervention for Bowel Preparation for Repeat Colonoscopy After Preparation Failure (RepeatPrep Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Preparation for Colonoscopy
Keywords: Colonoscopy
Educational intervention
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Hospital Universitario de Canarias
First posted: 2017-02-16
Enrollment: 657
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Adequate bowel cleansing for colonoscopy
timeFrame: At the moment of colonoscopy
Secondary outcomes:
measure: Overall adenoma detection rate, as defined by the ratio of patients with at least one adenoma in the overall colon
timeFrame: At the moment of colonoscopy
measure: Adenoma detection rate in the right colon
timeFrame: At the moment of colonoscopy
measure: Overall serrated lesion detection rate
timeFrame: At the moment of colonoscopy
measure: Serrated lesion detection rate in the right colon
timeFrame: At the moment of colonoscopy
measure: Complete colonoscopy rate
timeFrame: At the moment of colonoscopy
measure: Boston Bowel Preparation Scale
timeFrame: At the moment of colonoscopy
measure: Barcelona Bowel Preparation Scale
timeFrame: At the momento of colonoscopy
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Manresa
country: Spain
facility: Althaia Hospital de Manresa
state: Barcelona
city: Terrassa
country: Spain
facility: Consorci Sanitari Terrassa
state: Barcelona
city: Viladecans
country: Spain
facility: Hospital de Viladecans
state: Barcelona
city: Aranda De Duero
country: Spain
facility: Hospital Santos Reyes
state: Burgos
city: Tenerife
country: Spain
facility: Hospital Universitario de Canarias
state: Canarias
city: Móstoles
country: Spain
facility: Hospital Universtiario de Móstoles
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Soria
country: Spain
facility: Hospital Santa Bárbara
city: Valladolid
country: Spain
facility: Hospital Rio Hortega
Study officials:
References:
citation: 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.
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. doi: 10.1111/j.1572-0241.2001.03874.x.
citation: 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.
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-blinded, randomised, controlled study. Gut. 2014 Jan;63(1):125-30. doi: 10.1136/gutjnl-2012-304292. Epub 2013 Mar 16.