Split-dose Bowel PreparationNCT01476735
Individual Approach for Bowel Preparation Before Colonoscopy
A study testing individual preparation for colonoscopy in people with Split-dose Bowel Preparation and Polyethylene Glycol Solution, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial summary
This is a prospective, randomized, single-blind study designed to evaluate the influence of individual approach on bowel preparation quality for colonoscopy. The investigators compare split-dose polyethylene glycol solution (PEG, Fortrans, Beaufour Ipsen) to modified split-dose PEG regarding predictors of inadequate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Split-dose Bowel Preparation, Polyethylene Glycol Solution, Risk Factors Inadequate Preparation
- What is being tested?
- individual preparation for colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 sitePoland
- Study dates
- Aug 2011to Mar 2013
- 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
- men and women more than 18 years of age undergoing colonoscopy for routine clinical indications
- provided written informed consent
Who cannot join
- lack of written informed consent or inability to provide informed consent or refusal to consent to the study
- pregnancy and breast feeding
- known allergy to PEG or bisakodyl
- presence of serious conditions such as severe cadiac, renal or metabolic diseases, major psychiatric illness or end-stage cancer disease requiring taking narcotic drugs
- colonoscopy performed under conscious sedation
Trial locations and contacts
1 site in 1 country.
Poland1 site
Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology
Warsaw, 02-781
About this study
Official title: A Prospective, Randomized, Single-blind Study Evaluating Individual Approach on Bowel Preparation Quality for Colonoscopy
This is a prospective, randomized, single-blind study designed to evaluate the influence of individual approach on bowel preparation quality for colonoscopy. The investigators compare split-dose polyethylene glycol solution (PEG, Fortrans, Beaufour Ipsen) to modified split-dose PEG regarding predictors of inadequate preparation for colonoscopy.
Read the detailed description
Up to 22% of patients are not good prepared for colonoscopy and it is caused of aborted procedures and increased costs. There are identified predictors of inadequate bowel preparation before colonoscopy, but we still don't know if an individual approach improve the quality of preparation.
- Conditions
- Split-dose Bowel Preparation, Polyethylene Glycol Solution, Risk Factors Inadequate Preparation
- Being tested
- individual preparation for colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individual preparation for colonoscopyOther
The volume of polyethylene glycol solution depends on risk factors presented in each patient. Time of administration of second dose will be confirmed according to the time of colonoscopy. In case of constipation an enema before colonoscopy will be administered. All patients will give educational booklet of preparation before colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| split-dose polyethylene glycol solution | Active comparator | first dose (1,5 l) of polyethylene glycol solution taken at 6-7.00 in the evening before colonoscopy, second dose (1,5 l) taken at 5.30-6.00 in the morning of a day of colonoscopy; additional bisacodyl taken at 12.00 at the day before colonoscopy Receives: Other: individual preparation for colonoscopy |
| Individual preparation for colonoscopy | Active comparator | Not described Receives: Other: individual preparation for colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the index of preparation quality for the whole colon
the percentage of patients with adequate bowel preparation; adequate preparation is defined as excellent, good and fair, inadequate is defined as poor or unprepared colon according to the Ottawa bowel preparation scale
Measured: 24 hours
Secondary outcomes (1)
compliance safety
number of patients with completion of preparation number of patients with side effects of preparation in each group
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Split-dose 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaroslaw Regula, MD, PhD, Study director, Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology, Warsaw, PolandMichal F. Kaminski, MD, Study chair, Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology, Warsaw, PolandDorota Wretowska, MD, Principal investigator, Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476735
- Sponsor's protocol ID
- Individual bowel preparation
- Status last verified
- Nov 2011
- First submitted
- 17 Nov 2011
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single-blind Study Evaluating Individual Approach on Bowel Preparation Quality for Colonoscopy
- ClinicalTrials.gov ID
- NCT01476735
- Acronym / sponsor ID
- Individual bowel preparation
- Conditions
- Split-dose Bowel Preparation, Polyethylene Glycol Solution, Risk Factors Inadequate Preparation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 22 Nov 2011 (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.
This is a prospective, randomized, single-blind study designed to evaluate the influence of individual approach on bowel preparation quality for colonoscopy. The investigators compare split-dose polyethylene glycol solution (PEG, Fortrans, Beaufour Ipsen) to modified split-dose PEG regarding predictors of inadequate preparation for colonoscopy.
Detailed description
Up to 22% of patients are not good prepared for colonoscopy and it is caused of aborted procedures and increased costs. There are identified predictors of inadequate bowel preparation before colonoscopy, but we still don't know if an individual approach improve the quality of preparation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| split-dose polyethylene glycol solution | Active comparator | Other: individual preparation for colonoscopyfirst dose (1,5 l) of polyethylene glycol solution taken at 6-7.00 in the evening before colonoscopy, second dose (1,5 l) taken at 5.30-6.00 in the morning of a day of colonoscopy; additional bisacodyl taken at 12.00 at the day before colonoscopy |
| Individual preparation for colonoscopy | Active comparator | Other: individual preparation for colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- men and women more than 18 years of age undergoing colonoscopy for routine clinical indications
- provided written informed consent
Key exclusion criteria (5 listed)
- lack of written informed consent or inability to provide informed consent or refusal to consent to the study
- pregnancy and breast feeding
- known allergy to PEG or bisakodyl
- presence of serious conditions such as severe cadiac, renal or metabolic diseases, major psychiatric illness or end-stage cancer disease requiring taking narcotic drugs
- colonoscopy performed under conscious sedation
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 |
|---|---|---|
| individual preparation for colonoscopyThe volume of polyethylene glycol solution depends on risk factors presented in each patient. Time of administration of second dose will be confirmed according to the time of colonoscopy. In case of constipation an enema before colonoscopy will be administered. All patients will give educational booklet of preparation before colonoscopy | Other | Individual preparation for colonoscopy, split-dose polyethylene glycol solution |
Primary outcome
the index of preparation quality for the whole colon
Time frame: 24 hours
the percentage of patients with adequate bowel preparation; adequate preparation is defined as excellent, good and fair, inadequate is defined as poor or unprepared colon according to the Ottawa bowel preparation scale
1 secondary outcome
compliance safety
Time frame: 24 hours
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 6 Apr 2018.
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.
Jaroslaw Regula, MD, PhD study director
Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology, Warsaw, Poland
Michal F. Kaminski, MD study chair
Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology, Warsaw, Poland
Dorota Wretowska, MD principal investigator
Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing individual preparation for colonoscopy in people with Split-dose Bowel Preparation and Polyethylene Glycol Solution, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
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 2 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 6 Apr 2018. 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 Poland. 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?
the index of preparation quality for the whole colon (time frame: 24 hours). 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 6 Apr 2018; AzTrials last refreshed its copy on 29 Oct 2026.