NCT03055689

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
657

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2018

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

1.4 years

First QC Date

February 14, 2017

Last Update Submit

April 25, 2019

Conditions

Bowel Preparation for Colonoscopy

Keywords

ColonoscopyEducational intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • Adenoma detection rate in the right colon

    At the moment of colonoscopy

  • Overall serrated lesion detection rate

    At the moment of colonoscopy

  • Serrated lesion detection rate in the right colon

    At the moment of colonoscopy

  • Complete colonoscopy rate

    At the moment of colonoscopy

  • +2 more secondary outcomes

Study Arms (2)

Educational telephone intervention

EXPERIMENTAL

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

Behavioral: Educational telephone intervention

Standard education for colonoscopy

ACTIVE COMPARATOR

The control group will receive standard education for bowel preparation at the time of colonoscopy scheduling

Behavioral: Standard education for colonoscopy

Interventions

Educational telephone interventionBEHAVIORAL

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

Educational telephone intervention
Standard education for colonoscopyBEHAVIORAL

Standard education for bowel preparation at the time of colonoscopy scheduling

Standard education for colonoscopy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08035, Spain

Location

Althaia Hospital de Manresa

Manresa, Barcelona, Spain

Location

Consorci Sanitari Terrassa

Terrassa, Barcelona, Spain

Location

Hospital de Viladecans

Viladecans, Barcelona, Spain

Location

Hospital Santos Reyes

Aranda de Duero, Burgos, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Canary Islands, 38320, Spain

Location

Hospital Universtiario de Móstoles

Móstoles, Madrid, Spain

Location

Hospital Del Mar

Barcelona, 08003, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08035, Spain

Location

Hospital Universitario de Burgos

Burgos, Spain

Location

Hospital 12 de Octubre

Madrid, Spain

Location

Hospital Gregorio Marañón

Madrid, Spain

Location

Hospital Santa Bárbara

Soria, Spain

Location

Hospital Rio Hortega

Valladolid, Spain

Location

Related 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-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.

    PMID: 27490086RESULT

  • 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.

    PMID: 11419832RESULT

  • 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.

    PMID: 22067188RESULT

  • 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.

    PMID: 23503044RESULT

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gastroenterologist deputy doctor, MD, PhD

Study Record Dates

First Submitted

February 14, 2017

First Posted

February 16, 2017

Study Start

January 30, 2017

Primary Completion

June 30, 2018

Study Completion

December 25, 2018

Last Updated

April 26, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(14)