Inadequate Preparation for Colonoscopy; Personalized Colonoscopy PreparationNCT04033250
Personalized Colonoscopy Preparation for Patients With Risk Factors for Inadequate Preparation
A study testing Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure in people with Inadequate Preparation for Colonoscopy; Personalized Colonoscopy Preparation, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Adequate bowel preparation is one of the most important quality measures in colonoscopy. Previous studies identified several factors associated with inadequate bowel preparation (IBP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inadequate Preparation for Colonoscopy; Personalized Colonoscopy Preparation
- What is being tested?
- Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2019to Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- previous IBP
- concurrent medical conditions (e.g. diabetes, constipation)
- medications (e.g. opioids and tricyclic antidepressants)
Who cannot join
- previous colonic resection
- patients with IBD
- active CRC
- chronic kidney disease at any stage
- congestive heart failure at any stage
- liver cirrhosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Colonoscopy Preparation for Patients With Risk Factors for Inadequate Preparation: A Randomized Control Trial
Adequate bowel preparation is one of the most important quality measures in colonoscopy. Previous studies identified several factors associated with inadequate bowel preparation (IBP). No study has attempted to assign a different regimen to patients based on the presence of risk factors for inadequate bowel preparation.
The aim of the study is to check if a personalized bowel preparation regimen based on risk factors for IBP, will lead to an overall improvement in bowel preparation during colonoscopy.
- Being tested
- Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedureDrug
Also called Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses
Bowel preparation
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm (group A) | Experimental | Patients with risk factors for IBP who will receive "intensified" bowel preparation Receives: Drug: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure |
| Control arm (group B) | Active comparator | Patients with risk factors for IBP who will receive standard bowel preparation Receives: Drug: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure |
| Control arm (group c) | Active comparator | Patients without risk factors for IPB who will receive standard bowel preparation Receives: Drug: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved bowel preparation
Boston Bowel Preparation Scale at index colonoscopy will be measured. The grading is between 1 and 3 for each segment of colon (ascending, transverse, descending) where 1 is poor and 3 is excellent (subscale). The final score is between 3 and 9 summing up the scores for each segment.
Measured: Index colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study startSep 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inadequate Preparation for Colonoscopy; Personalized Colonoscopy 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Klein MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033250
- Sponsor's protocol ID
- 0117-19-RMB CTIL
- Status last verified
- Sep 2019
- First submitted
- 24 Jul 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Colonoscopy Preparation for Patients With Risk Factors for Inadequate Preparation: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04033250
- Acronym / sponsor ID
- 0117-19-RMB CTIL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Jul 2019 (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.
Adequate bowel preparation is one of the most important quality measures in colonoscopy. Previous studies identified several factors associated with inadequate bowel preparation (IBP). No study has attempted to assign a different regimen to patients based on the presence of risk factors for inadequate bowel preparation.
The aim of the study is to check if a personalized bowel preparation regimen based on risk factors for IBP, will lead to an overall improvement in bowel preparation during colonoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interventional arm (group A) | Experimental | Drug: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedurePatients with risk factors for IBP who will receive "intensified" bowel preparation |
| Control arm (group B) | Active comparator | Drug: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedurePatients with risk factors for IBP who will receive standard bowel preparation |
| Control arm (group c) | Active comparator | Drug: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedurePatients without risk factors for IPB who will receive standard bowel preparation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- previous IBP
- concurrent medical conditions (e.g. diabetes, constipation)
- medications (e.g. opioids and tricyclic antidepressants)
Key exclusion criteria (6 listed)
- previous colonic resection
- patients with IBD
- active CRC
- chronic kidney disease at any stage
- congestive heart failure at any stage
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 |
|---|---|---|
| Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedureAlso: Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split dosesBowel preparation | Drug | Control arm (group B), Control arm (group c), Interventional arm (group A) |
Primary outcome
Improved bowel preparation
Time frame: Index colonoscopy
Boston Bowel Preparation Scale at index colonoscopy will be measured. The grading is between 1 and 3 for each segment of colon (ascending, transverse, descending) where 1 is poor and 3 is excellent (subscale). The final score is between 3 and 9 summing up the scores for each segment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure in people with Inadequate Preparation for Colonoscopy; Personalized Colonoscopy Preparation, run by Rambam Health Care Campus at 1 site in Israel.
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 6 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 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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 Klein, MD (+972-4-7773625, am_klein@rmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved bowel preparation (time frame: Index colonoscopy). 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 25 Sep 2019.