Bowel PreparationPhase 4NCT02908919
Impact of Time Intervals of Preparation on Quality and Tolerance of the Bowel Preparation
A Phase 4 study testing Colonoscopy in people with Bowel Preparation and Colonoscopy, run by Faculty Hospital Kralovske Vinohrady at 2 sites in Czechia.
Trial summary
The purpose of this study is to determine optimal time intervals for preparation before colonoscopy using different formulas. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Bowel Preparation, Colonoscopy
- What is being tested?
- Colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 2 sitesCzechia
- Study dates
- Aug 2016to Dec 2016
- Phase
- Phase 4
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects referred to diagnostic or therapeutic colonoscopy.
Who cannot join
- ileus
- known or suspected bowel obstruction
- active bowel inflammation
- pregnancy
- any presence of serious medical conditions ( esp. cardiac, renal, liver diseases)
- history of prior colonic or rectal surgery
- inability to obtain valid data from
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites, 2 recruiting
- Recruiting
Faculty Hospital Kralovske Vinohrady
Prague, 10024
Jan Matous, MD, +420267163680, jan.matous1@fnkv.cz
- Recruiting
Nemocnice T.Bati
Zlín, 76275
Vladimir Kojecky, MD,PhD, +420577552512, kojecky@bnzlin.cz
About this study
Official title: Impact of Time Intervals on Quality and Tolerance of the Bowel Preparation
The purpose of this study is to determine optimal time intervals for preparation before colonoscopy using different formulas.
Read the detailed description
Different formulas are used for bowel preparation before colonoscopy. Present guidelines are based on conventional polyethylene glycol. Their validity for other preparations were not evaluated. Relationship between length of preparation, interval to colonoscopy and bowel preparation quality, tolerance are assessed.
- Conditions
- Bowel Preparation, Colonoscopy
- Being tested
- Colonoscopy
- Keywords
- Colonoscopy, Picosulfate sodium, Polyethylene glycol, Magnesium citrate, Ascorbic acid, SPMC (solution picosulfate + magnesium citrate), PEGA (Polyethylene glycol + ascorbic acid)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
The quality of bowel preparation, which is checked during colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Fortrans pulv. sol | Active comparator | Polyethylene glycol solution. Used 4 l before colonoscopy. Bowel preparation interval: QD/BID or one day. Receives: Procedure: Colonoscopy |
| Picoprep pulv. sol. | Active comparator | Natrium picosulfate/ magnesium citrate solution. Used 2 l before colonoscopy. bowel preparation interval: QD/BID or one day. Receives: Procedure: Colonoscopy |
| Moviprep pulv. sol. | Active comparator | Polyethylene glycol + ascorbic acid solution. Used 2 l before colonoscopy. Bowel preparation interval: QD/BID or one day. Receives: Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of bowel preparation according to time intervals of bowel preparation
The length of bowel preparation and interval to colonoscopy for bowel preparation quality Aronchick score excellent and good
Measured: One day
Secondary outcomes (1)
Tolerance of bowel preparation according to time intervals of bowel preparation
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty Hospital Kralovske Vinohrady
- Sponsor type
- Other government
- Collaborators
- Nemocnice T.Bati, Zlin, Brno University Hospital, University Hospital, Motol
- Responsible party
- Principal investigator, MUDr. Jan Matous, Faculty Hospital Kralovske Vinohrady
- Investigators
- Jan Matous, MD, Principal investigator, Faculty Hospital Kralovske Vinohrady, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908919
- Sponsor's protocol ID
- CB1601
- Status last verified
- Nov 2016
- First submitted
- 9 Sep 2016
- Last updated
- 3 Nov 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 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Time Intervals on Quality and Tolerance of the Bowel Preparation
- ClinicalTrials.gov ID
- NCT02908919
- Acronym / sponsor ID
- CB1601
- Conditions
- Bowel Preparation, Colonoscopy
- Keywords
- Colonoscopy, Picosulfate sodium, Polyethylene glycol, Magnesium citrate, Ascorbic acid, SPMC (solution picosulfate + magnesium citrate), PEGA (Polyethylene glycol + ascorbic acid)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Faculty Hospital Kralovske VinohradyOther government
- Collaborators
- Nemocnice T.Bati, Zlin, Brno University Hospital, University Hospital, Motol
- Study start
- Aug 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 21 Sep 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.
The purpose of this study is to determine optimal time intervals for preparation before colonoscopy using different formulas.
Detailed description
Different formulas are used for bowel preparation before colonoscopy. Present guidelines are based on conventional polyethylene glycol. Their validity for other preparations were not evaluated. Relationship between length of preparation, interval to colonoscopy and bowel preparation quality, tolerance are assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fortrans pulv. sol | Active comparator | Procedure: ColonoscopyPolyethylene glycol solution. Used 4 l before colonoscopy. Bowel preparation interval: QD/BID or one day. |
| Picoprep pulv. sol. | Active comparator | Procedure: ColonoscopyNatrium picosulfate/ magnesium citrate solution. Used 2 l before colonoscopy. bowel preparation interval: QD/BID or one day. |
| Moviprep pulv. sol. | Active comparator | Procedure: ColonoscopyPolyethylene glycol + ascorbic acid solution. Used 2 l before colonoscopy. Bowel preparation interval: QD/BID or one day. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subjects referred to diagnostic or therapeutic colonoscopy.
Key exclusion criteria (7 listed)
- ileus
- known or suspected bowel obstruction
- active bowel inflammation
- pregnancy
- any presence of serious medical conditions ( esp. cardiac, renal, liver diseases)
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 |
|---|---|---|
| ColonoscopyThe quality of bowel preparation, which is checked during colonoscopy | Procedure or surgery | Fortrans pulv. sol, Moviprep pulv. sol., Picoprep pulv. sol. |
Primary outcome
Quality of bowel preparation according to time intervals of bowel preparation
Time frame: One day
The length of bowel preparation and interval to colonoscopy for bowel preparation quality Aronchick score excellent and good
1 secondary outcome
Tolerance of bowel preparation according to time intervals of bowel preparation
Time frame: One day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 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.
Jan Matous, MD principal investigator
Faculty Hospital Kralovske Vinohrady, Prague
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colonoscopy in people with Bowel Preparation and Colonoscopy, run by Faculty Hospital Kralovske Vinohrady at 2 sites in Czechia.
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: status not confirmed, as of the sponsor's last update on 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jan Matous, MD (+420267163680, jan.matous1@fnkv.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of bowel preparation according to time intervals of bowel preparation (time frame: One day). 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 3 Nov 2016.