Colonoscopy: Bowel PreparationNCT02287051
Bowel Prep Acceptance in Clinical Practice
An observational study of Colonoscopy: Bowel Preparation, run by Valduce Hospital.
Trial summary
Bowel preparation for colonoscopy is crucial, since the diagnostic accuracy of the procedure depends on an adequate visualization of the mucosa of the colon.There is strong evidence that the quality of bowel preparation is inversely correlated with the interval between the end of the assumption of the purgative and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonoscopy: Bowel Preparation
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Oct 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: population undergoing colonoscopy
Who may be able to join
- adult patientes undergoing colonscopy
Who cannot join
- afternoon colonoscopy
- partial colonoscopy
- ASA III-IV
- pregnancy
- incapacity to give informed consent
About this study
Official title: Acceptance and Compliance of Split-dose Bowel Preparation for Colonoscopy in Clinical Practice
Bowel preparation for colonoscopy is crucial, since the diagnostic accuracy of the procedure depends on an adequate visualization of the mucosa of the colon.There is strong evidence that the quality of bowel preparation is inversely correlated with the interval between the end of the assumption of the purgative and the start of colonoscopy (shorter intervals are associated with higher levels of preparation).Recent studies have shown that split dose prep significantly improves the quality of bowel cleansing. In light of these data, both the American College of Gastroenterology (ACG) and the European Society of Gastrointestinal Endoscopy (ESGE) recommend now split dose prep in order to improve the quality of bowel cleansing. Despite these recommendations, the uptake of schemes in divided doses appears clearly underused in actual clinical practice. In particular, in Italy only a few centers routinely adopt the regime split as their first choice for the preparation for colonoscopy.The reasons why the "split dose" is under-utilized in clinical practice are not entirely clear, but probably in part reflecting gastroenterologists' concerns about potential elements that theoretically could make it less acceptable to the patient (get up early in the morning, potential problems during the journey from home to the hospital) The hypothesis of the study is that many patients would still be willing to accept these potential drawbacks if they were adequately informed about the positive impact of the scheme in divided doses on the effectiveness of bowel preparation, which results in higher reliability of the examination, shorter duration of the procedure, and less risk of rescheduling the exam in the near future
- Conditions
- Colonoscopy: Bowel Preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| colonoscopy population | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
acceptance
structured questionnaire on acceptability and problems related to the modality of the preparation
Measured: 3 month
compliance
structured questionnaire on completeness and difficulties related to the modality of the preparation
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonoscopy: Bowel PreparationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valduce Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnaldo Amato, Valduce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287051
- Sponsor's protocol ID
- 7/14
- Status last verified
- Nov 2014
- First submitted
- 12 Oct 2014
- Last updated
- 10 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Radaelli F, Paggi S, Repici A, Gullotti G, Cesaro P, Rotondano G, Cugia L, Trovato C, Spada C, Fuccio L, Occhipinti P, Pace F, Fabbri C, Buda A, Manes G, Feliciangeli G, Manno M, Barresi L, Anderloni A, Dulbecco P, Rogai F, Amato A, Senore C, Hassan C. Barriers against split-dose bowel preparation for colonoscopy. Gut. 2017 Aug;66(8):1428-1433. doi: 10.1136/gutjnl-2015-311049. Epub 2016 Apr 19.
PubMed 27196589
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Compliance of Split-dose Bowel Preparation for Colonoscopy in Clinical Practice
- ClinicalTrials.gov ID
- NCT02287051
- Acronym / sponsor ID
- 7/14
- Conditions
- Colonoscopy: Bowel Preparation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Valduce HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 10 Nov 2014 (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.
Bowel preparation for colonoscopy is crucial, since the diagnostic accuracy of the procedure depends on an adequate visualization of the mucosa of the colon.There is strong evidence that the quality of bowel preparation is inversely correlated with the interval between the end of the assumption of the purgative and the start of colonoscopy (shorter intervals are associated with higher levels of preparation).Recent studies have shown that split dose prep significantly improves the quality of bowel cleansing. In light of these data, both the American College of Gastroenterology (ACG) and the European Society of Gastrointestinal Endoscopy (ESGE) recommend now split dose prep in order to improve the quality of bowel cleansing. Despite these recommendations, the uptake of schemes in divided doses appears clearly underused in actual clinical practice. In particular, in Italy only a few centers routinely adopt the regime split as their first choice for the preparation for colonoscopy.The reasons why the "split dose" is under-utilized in clinical practice are not entirely clear, but probably in part reflecting gastroenterologists' concerns about potential elements that theoretically could make it less acceptable to the patient (get up early in the morning, potential problems during the journey from home to the hospital) The hypothesis of the study is that many patients would still be willing to accept these potential drawbacks if they were adequately informed about the positive impact of the scheme in divided doses on the effectiveness of bowel preparation, which results in higher reliability of the examination, shorter duration of the procedure, and less risk of rescheduling the exam in the near future
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| colonoscopy population | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- population undergoing colonoscopy
Key inclusion criteria (1 listed)
- adult patientes undergoing colonscopy
Key exclusion criteria (5 listed)
- afternoon colonoscopy
- partial colonoscopy
- ASA III-IV
- pregnancy
- incapacity to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
acceptance
Time frame: 3 month
structured questionnaire on acceptability and problems related to the modality of the preparation
compliance
Time frame: 3 month
structured questionnaire on completeness and difficulties related to the modality of the preparation
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 10 Nov 2014.
- Derived from this study: PubMed 27196589Radaelli F, Paggi S, Repici A, Gullotti G, Cesaro P, Rotondano G, Cugia L, Trovato C, Spada C, Fuccio L, Occhipinti P, Pace F, Fabbri C, Buda A, Manes G, Feliciangeli G, Manno M, Barresi L, Anderloni A, Dulbecco P, Rogai F, Amato A, Senore C, Hassan C. Barriers against split-dose bowel preparation for colonoscopy. Gut. 2017 Aug;66(8):1428-1433. doi: 10.1136/gutjnl-2015-311049. Epub 2016 Apr 19.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy: Bowel Preparation, run by Valduce Hospital.
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 5 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 10 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
acceptance (time frame: 3 month). The study lists 2 primary outcomes in all. 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 NCT02287051, which also lists 1 linked publication.
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 10 Nov 2014.