ColonoscopyPREPA-CONCT02712073
Predictive Score of the Bowel Preparation Quality Based on a Self-administered Questionnaire
An observational study of Colonoscopy, run by University Hospital, Angers at 4 sites in France.
Trial summary
In France, nearly 1.3 million colonoscopies are performed each year. Colonoscopy is the gold standard in France for colorectal cancer screening in populations at risk. However, it has a number of limitations. The quality of the bowel preparation is a critical step for the successful completion of this examination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Questionnaire
- How many people
- 1,260 participants
- Where
- 4 sitesFrance
- Study dates
- May 2015to Sep 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients seen in precolonoscopy consultation
Who may be able to join
- Men or woman > 18 years old
- Patient agreeing to participate in the study
- Prescription of a bowel preparation respecting the marketing authorization.
Who cannot join
- Major patient under guardianship, or protected person,
- Pregnant woman,
- Patient who doesn't understand French or can't read
- People not affiliated with a social security scheme or of such a scheme
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
Angers UH
Angers
Elodie Cesbron-Métivier, MD, +33241356054, ElMetivier@chu-angers.fr
Nathanaëlle Cornet, +33241356054, nathanaelle.cornet@chu-angers.fr
- Not yet recruiting
Cholet hospital
Cholet
Mehdi Kaassis
- Not yet recruiting
La Roche sur Yon hospital
La Roche-sur-Yon
Morgane Amil
- Not yet recruiting
Nantes UH
Nantes
Emmanuel Coron, MD
About this study
In France, nearly 1.3 million colonoscopies are performed each year. Colonoscopy is the gold standard in France for colorectal cancer screening in populations at risk. However, it has a number of limitations. The quality of the bowel preparation is a critical step for the successful completion of this examination. The occurrence of interval cancers raises the problem of missed lesions. A literature review showed that there were differences between the endoscopy units on quality standards for bowel preparation. The rate of unprepared colonoscopy is estimated between 20 to 40% . In a recent cohort study, 28% of 2516 colonoscopies had a score of Boston of less than or equal to 6. These colonoscopies generate substantial additional costs to redo colonoscopies, estimated at 35 million euros in 2008. The establishment a predictive score for quality of bowel preparation based on a self-administered questionnaire completed by patients during the pre-colonoscopy consultation, would help identify patients at risk of poor preparation in order to optimize the prescribed preparation in this consultation.
- Conditions
- Colonoscopy
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Self administered questionnaire to evaluate the preparation quality of colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing colonoscopy | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score performance
score performance to predict a poor bowel preparation (defined by a score of Boston inferior or equal to 7 and / or a segment equal to 1)
Measured: within 6 month
Secondary outcomes (2)
acceptability of questionnaire
Acceptability of the questionnaire evaluated by the rate of return of the questionnaires and the rate of well completed questionnaires
Measured: end of study
Adenoma detection
adenoma detection rate compared to Boston score
Measured: within 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startMay 2015
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712073
- Sponsor's protocol ID
- DRCI V11 01/01/2015
- Acronym
- PREPA-CO
- Status last verified
- Apr 2016
- First submitted
- 14 Mar 2016
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Score of the Bowel Preparation Quality Based on a Self-administered Questionnaire
- ClinicalTrials.gov ID
- NCT02712073
- Acronym / sponsor ID
- PREPA-CO / DRCI V11 01/01/2015
- Conditions
- Colonoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,260 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- May 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 17 Mar 2016 (estimated)
- 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.
In France, nearly 1.3 million colonoscopies are performed each year. Colonoscopy is the gold standard in France for colorectal cancer screening in populations at risk. However, it has a number of limitations. The quality of the bowel preparation is a critical step for the successful completion of this examination. The occurrence of interval cancers raises the problem of missed lesions. A literature review showed that there were differences between the endoscopy units on quality standards for bowel preparation. The rate of unprepared colonoscopy is estimated between 20 to 40% . In a recent cohort study, 28% of 2516 colonoscopies had a score of Boston of less than or equal to 6. These colonoscopies generate substantial additional costs to redo colonoscopies, estimated at 35 million euros in 2008. The establishment a predictive score for quality of bowel preparation based on a self-administered questionnaire completed by patients during the pre-colonoscopy consultation, would help identify patients at risk of poor preparation in order to optimize the prescribed preparation in this consultation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing colonoscopy | – | Other: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen in precolonoscopy consultation
Key inclusion criteria (3 listed)
- Men or woman > 18 years old
- Patient agreeing to participate in the study
- Prescription of a bowel preparation respecting the marketing authorization.
Key exclusion criteria (4 listed)
- Major patient under guardianship, or protected person,
- Pregnant woman,
- Patient who doesn't understand French or can't read
- People not affiliated with a social security scheme or of such a scheme
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 |
|---|---|---|
| QuestionnaireSelf administered questionnaire to evaluate the preparation quality of colonoscopy | Other | patients undergoing colonoscopy |
Primary outcome
Score performance
Time frame: within 6 month
score performance to predict a poor bowel preparation (defined by a score of Boston inferior or equal to 7 and / or a segment equal to 1)
2 secondary outcomes
acceptability of questionnaire
Time frame: end of study
Adenoma detection
Time frame: within 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy, run by University Hospital, Angers at 4 sites in France.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elodie Cesbron-Métivier, MD (+33241356054, ElMetivier@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score performance (time frame: within 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2016.