Bowel Preparation for ColonoscopyNCT03055689
Bowel Preparation for Repeat Colonoscopy After Preparation Failure (RepeatPrep Study)
A study testing Educational telephone intervention and Standard education for colonoscopy in people with Bowel Preparation for Colonoscopy, run by Parc de Salut Mar at 14 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bowel Preparation for Colonoscopy
- What is being tested?
- Educational telephone intervention and Standard education for colonoscopy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 657 participants
- Where
- 14 sitesSpain
- Study dates
- 30 Jan 2017to 25 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites
Hospital Santos Reyes
Aranda de Duero, Burgos
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08035
Hospital Del Mar
Barcelona, 08003
Hospital de la Santa Creu i Sant Pau
Barcelona, 08035
Hospital Universitario de Burgos
Burgos
Hospital 12 de Octubre
Madrid
Hospital Gregorio Marañón
Madrid
Althaia Hospital de Manresa
Manresa, Barcelona
Hospital Universtiario de Móstoles
Móstoles, Madrid
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, 38320
Hospital Santa Bárbara
Soria
Consorci Sanitari Terrassa
Terrassa, Barcelona
Hospital Rio Hortega
Valladolid
Hospital de Viladecans
Viladecans, Barcelona
About this study
Official title: Nurse-led Educational Telephone Intervention for 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.
- Conditions
- Bowel Preparation for Colonoscopy
- Being tested
- Educational telephone intervention, Standard education for colonoscopy
- Keywords
- Colonoscopy, Educational intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational telephone interventionBehavioural
Subjects will receive a nurse-led educational telephone intervention for bowel preparation 24-48 hours before the colonoscopy
Standard education for colonoscopyBehavioural
Standard education for bowel preparation at the time of colonoscopy scheduling
| Study group | Role | What they receive |
|---|---|---|
| Educational telephone intervention | Experimental | This group will receive a nurse-led educational telephone intervention for bowel preparation 24-48 before the colonoscopy Receives: 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 Receives: Behavioral: Standard education for colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The ratio of patients with at least one adenoma in the overall colon
Measured: At the moment of colonoscopy
Adenoma detection rate in the right colon
Ratio of patients with at least one adenoma in the right colon (proximal to the splenic flexure)
Measured: At the moment of colonoscopy
Overall serrated lesion detection rate
Ratio of patients with at least one serrated lesion in the overall colon
Measured: At the moment of colonoscopy
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)
Measured: At the moment of colonoscopy
Complete colonoscopy rate
Ratio of successful complete colonoscopies (cecal intubation or in case of previous surgery, ileocolic anastomosis)
Measured: At the moment of colonoscopy
Boston Bowel Preparation Scale
Application of the Boston Bowel Preparation Scale to evaluate colonoscopy bowel cleansing
Measured: At the moment of colonoscopy
Barcelona Bowel Preparation Scale
Application of the Barcelona Bowel Preparation Scale to evaluate colonoscopy bowel cleansing
Measured: At the momento of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start30 Jan 2017
- Primary completion30 Jun 2018
- Study completion25 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bowel Preparation for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 657 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario de Canarias
- Responsible party
- Principal investigator, Marco Antonio Alvarez Gonzalez, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055689
- Sponsor's protocol ID
- REPEATPREP
- Status last verified
- Apr 2019
- First submitted
- 14 Feb 2017
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27490086Ness 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.
PubMed 11419832Ibanez 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.
PubMed 22067188Liu 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.
PubMed 23503044
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-led Educational Telephone Intervention for Bowel Preparation for Repeat Colonoscopy After Preparation Failure (RepeatPrep Study)
- ClinicalTrials.gov ID
- NCT03055689
- Acronym / sponsor ID
- REPEATPREP
- Conditions
- Bowel Preparation for Colonoscopy
- Keywords
- Colonoscopy, Educational intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 657 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Hospital Universitario de Canarias
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 25 Dec 2018 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational telephone intervention | Experimental | Behavioral: Educational telephone interventionThis group will receive a nurse-led educational telephone intervention for bowel preparation 24-48 before the colonoscopy |
| Standard education for colonoscopy | Active comparator | Behavioral: Standard education for colonoscopyThe control group will receive standard education for bowel preparation at the time of colonoscopy scheduling |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational telephone interventionSubjects will receive a nurse-led educational telephone intervention for bowel preparation 24-48 hours before the colonoscopy | Behavioural | Educational telephone intervention |
| Standard education for colonoscopyStandard education for bowel preparation at the time of colonoscopy scheduling | Behavioural | Standard education for colonoscopy |
Primary outcome
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.
7 secondary outcomes
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
Adenoma detection rate in the right colon
Time frame: At the moment of colonoscopy
Overall serrated lesion detection rate
Time frame: At the moment of colonoscopy
Serrated lesion detection rate in the right colon
Time frame: At the moment of colonoscopy
Complete colonoscopy rate
Time frame: At the moment of colonoscopy
Boston Bowel Preparation Scale
Time frame: At the moment of colonoscopy
Barcelona Bowel Preparation Scale
Time frame: At the momento of colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Results publication: PubMed 27490086Alvarez-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.
- Results publication: PubMed 11419832Ness 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.
- Results publication: PubMed 22067188Ibanez 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.
- Results publication: PubMed 23503044Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational telephone intervention and Standard education for colonoscopy in people with Bowel Preparation for Colonoscopy, run by Parc de Salut Mar at 14 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate bowel cleansing for colonoscopy (time frame: At the moment of colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03055689, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.