Colonoscopy PreparationPhase 4NCT01531140
PEG Versus PEG+Bisacodyl Versus Sennosides for Colon Cleansing Before Colonoscopy
A Phase 4 study testing polyethylene glycol +Bisacodyl, Polyethylene glycol and Sennosides in people with Colonoscopy Preparation, run by Medical University of Warsaw at 2 sites in Poland.
Trial summary
Background: Polyethylene glycol (PEG) solution has been proven to be effective for large bowel cleansing prior to colonoscopy in children. However, the high volume of fluid and its taste sometimes lead to inappropriate cleansing of the bowel, thus search for other bowel preparation is needed. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Colonoscopy Preparation
- What is being tested?
- polyethylene glycol +Bisacodyl, Polyethylene glycol and Sennosides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesPoland
- Study dates
- Nov 2010to Nov 2011
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children 10 - 18 years of age referred for colonoscopy
- informed consent signed
Who cannot join
- allergy to PEG, sennosides or bisacodyl
- disorders that make oral intake of the preparation impossible (neurological disorders, intestinal obstruction, mental retardation etc.)
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Warsaw Medical University
Warsaw, 01-184
Child Health Center
Warsaw, 04-730
About this study
Official title: High-volume Polyethylene Glycol Solution (PEG) Versus Low-volume PEG Plus Stimulant Laxative Versus Sennosides for Colon Cleansing Before Colonoscopy: a Randomized, Single Blinded Study
Background:
Polyethylene glycol (PEG) solution has been proven to be effective for large bowel cleansing prior to colonoscopy in children. However, the high volume of fluid and its taste sometimes lead to inappropriate cleansing of the bowel, thus search for other bowel preparation is needed.
Read more
Aim:
The efficacy and tolerability of three different bowel cleansing protocols used in children for colonoscopy: high-volume PEG compared with low-volume PEG with stimulant laxative (bisacodyl) compared with sennosides.
Methods:
Participants aged 10-18 years will be randomly assigned to receive either PEG 60 ml/kg/day or PEG 30 ml/kg/day plus oral bisacodyl 10-15 mg/day or sennosides 2mg/kg/day for 2 days prior to the colonoscopy. The outcome measures will be:bowel cleansing efficacy, scored by a blinded endoscopist using the Ottawa scale and Aronchick Scale (the mean total score, proportions of participants with excellent/good and with poor/inadequate bowel preparation), and the patient satisfaction score(0-10)with the method of preparation for the colonoscopy evaluated with the visual analog scale. Analysis will be done on an intention to treat basis.
Read the detailed description
Patients are excluded if they had known allergy to one of the tested preparations such as bisacodyl (Bisacodyl VP, ICN Polfa, Rzeszow, Poland), polyethylene glycol (Fortrans, Beaufour Ipsen Industry, Dreux, France) and/or sennoside (Xenna Extra, US Pharmacia, Wroclaw, Poland) and had disorders that make oral intake of the preparation impossible (neurological disorders, intestinal obstruction, mental retardation etc.).
Study design:
On admission day patients are allocated to one of the groups by study investigators, according to the randomization list created by an independent person using block randomization by a standard statistical program StatsDirect [version 2,3,8 (2005)] (6 patients were included in each block).
During the preparation for colonoscopy each patient are observed for procedure tolerance. On the day of endoscopy, each patient evaluated the degree of the acceptance of the method of bowel cleaning (according to visual analog scale (VAS) and the occurrence of side effects (diary). The endoscopist performing colonoscopy, blinded for the bowel preparation regimen evaluate bowel cleansing and score it, according to the Aronchick and Ottawa scale. The rate of cecum intubation, and the colonoscopy complications (defined as bowel perforation and/or significant bleeding) are analyzed in each bowel preparation group.
- Conditions
- Colonoscopy Preparation
- Being tested
- polyethylene glycol +Bisacodyl, Polyethylene glycol, Sennosides
- Keywords
- colonoscopy cleansing, PEG, sennosides, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyethylene glycol +BisacodylDrug
Also called Polyethylene glycol: Fortrans
Polyethylene glycol (Fortrans) p.o. 30 ml/kg/2days + Bisacodyl p.o.10-15 mg/day for 2 days
Polyethylene glycolDrug
Also called Polyethylene glycol: Fortrans
Polyethylene glycol p.o.: 60 ml/kg/days
SennosidesDrug
Also called Sennosides: Xenna
Sennosides 1tbl/8kg for 2 days
| Study group | Role | What they receive |
|---|---|---|
| Polyethylene glycol | Active comparator | Polyethylene glycol p.o.(Fortrans):60 ml/kg for 2 days Receives: Drug: Polyethylene glycol |
| PEG + Bisacodyl | Experimental | Polyethylene glycol p.o.(Fortrans): 30 ml/kg for 2 days + Bisacodyl p.o.: 10-15 mg/day Receives: Drug: polyethylene glycol +Bisacodyl |
| Sennosides | Experimental | Sennosides: 1tbl/8kg/day for 2 days (1 tbl=8,6 mg sennosides B) Receives: Drug: Sennosides |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportions of participants with good or excellent bowel preparation assessed with Ottawa Scale
According to the Ottawa scale the quality of bowel preparation is estimated by adding points for the cleansing of three parts of colon (descending, transversal and ascending) and points for amount of fluid in the bowel. Score: 0-1 - excellent cleansing, 2-4 - good, 5-7 - sufficient, 8-10 - poor, 11-14 - not appropriate.
Measured: bowel preparation quality with Ottawa scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
proportions of participants with poor/inadequate bowel preparation assessed with Ottawa Scale
According to the Ottawa scale the quality of bowel preparation is estimated by adding points for the cleansing of three parts of colon (descending, transversal and ascending) and points for amount of fluid in the bowel. Score: 0-1 - excellent cleansing, 2-4 - good, 5-7 - sufficient, 8-10 - poor, 11-14 - not appropriate.
Measured: bowel preparation quality with Ottawa scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
Secondary outcomes (5)
proportions of participants with very good/good bowel preparation assessed with Aronchick Scale
According to Aronchick scale preparation is estimated as:
- very good: small amount of clear fluid is present, more than 95% mucosa is visible
- good: small amount of clear fluid easy to suction away or flush is present, more than 90% of mucosa is visible
- sufficient: big amount of clear fluid covering 5-25% of mucosa, more than 90% of mucosa visible
- poor: semi-liquid stool that cannot be flushed, less than 90% of mucosa visible
- inadequate: colonoscopy must be repeated
Measured: bowel preparation quality with Aronchick scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
proportions of participants with poor/inadequate bowel preparation assessed with Aronchick Scale
According to Aronchick scale preparation is estimated as:
- very good: small amount of clear fluid is present, more than 95% mucosa is visible
- good: small amount of clear fluid easy to suction away or flush is present, more than 90% of mucosa is visible
- sufficient: big amount of clear fluid covering 5-25% of mucosa, more than 90% of mucosa visible
- poor: semi-liquid stool that cannot be flushed, less than 90% of mucosa visible
- inadequate: colonoscopy must be repeated
Measured: bowel preparation quality with Aronchick scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
mean bowel preparation score assessed with Ottawa Scale
According to the Ottawa scale the quality of bowel preparation is estimated by adding points for the cleansing of three parts of colon (descending, transversal and ascending) and points for amount of fluid in the bowel. Score: 0-1 - excellent cleansing, 2-4 - good, 5-7 - sufficient, 8-10 - poor, 11-14 - not appropriate.
Measured: bowel preparation quality with Ottawa scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
mean bowel preparation score assessed with Aronchick scale
According to Aronchick scale preparation is estimated as:
- very good: small amount of clear fluid is present, more than 95% mucosa is visible
- good: small amount of clear fluid easy to suction away or flush is present, more than 90% of mucosa is visible
- sufficient: big amount of clear fluid covering 5-25% of mucosa, more than 90% of mucosa visible
- poor: semi-liquid stool that cannot be flushed, less than 90% of mucosa visible
- inadequate: colonoscopy must be repeated
Measured: bowel preparation quality with Aronchick scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
patient satisfaction with the method of preparation assessed with Visual analogue scale (VAS)
VAS scale is horizontal line 100 mm lenght anchored by word description at each end (very good, very bad).The patient mark on the line the point that feel represent the perception of bowel preparation regimen.
Measured: assessed by patient after completion of bowel preparation regimen before colonoscopy (3rd day of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startNov 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonoscopy PreparationStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Child Health
- Responsible party
- Sponsor
- Investigators
- Piotr Dziechciarz, MD, Study chair, Medical University of WarsawJaroslaw Kierkus, MD, Principal investigator, Child Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531140
- Sponsor's protocol ID
- 1/2012
- Status last verified
- Jan 2012
- First submitted
- 16 Jan 2012
- Last updated
- 10 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-volume Polyethylene Glycol Solution (PEG) Versus Low-volume PEG Plus Stimulant Laxative Versus Sennosides for Colon Cleansing Before Colonoscopy: a Randomized, Single Blinded Study
- ClinicalTrials.gov ID
- NCT01531140
- Acronym / sponsor ID
- 1/2012
- Conditions
- Colonoscopy Preparation
- Keywords
- colonoscopy cleansing, PEG, sennosides, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Institute of Child Health
- Study start
- Nov 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 10 Feb 2012 (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.
Background:
Polyethylene glycol (PEG) solution has been proven to be effective for large bowel cleansing prior to colonoscopy in children. However, the high volume of fluid and its taste sometimes lead to inappropriate cleansing of the bowel, thus search for other bowel preparation is needed.
Aim:
The efficacy and tolerability of three different bowel cleansing protocols used in children for colonoscopy: high-volume PEG compared with low-volume PEG with stimulant laxative (bisacodyl) compared with sennosides.
Methods:
Participants aged 10-18 years will be randomly assigned to receive either PEG 60 ml/kg/day or PEG 30 ml/kg/day plus oral bisacodyl 10-15 mg/day or sennosides 2mg/kg/day for 2 days prior to the colonoscopy. The outcome measures will be:bowel cleansing efficacy, scored by a blinded endoscopist using the Ottawa scale and Aronchick Scale (the mean total score, proportions of participants with excellent/good and with poor/inadequate bowel preparation), and the patient satisfaction score(0-10)with the method of preparation for the colonoscopy evaluated with the visual analog scale. Analysis will be done on an intention to treat basis.
Detailed description
Patients are excluded if they had known allergy to one of the tested preparations such as bisacodyl (Bisacodyl VP, ICN Polfa, Rzeszow, Poland), polyethylene glycol (Fortrans, Beaufour Ipsen Industry, Dreux, France) and/or sennoside (Xenna Extra, US Pharmacia, Wroclaw, Poland) and had disorders that make oral intake of the preparation impossible (neurological disorders, intestinal obstruction, mental retardation etc.).
Study design:
On admission day patients are allocated to one of the groups by study investigators, according to the randomization list created by an independent person using block randomization by a standard statistical program StatsDirect [version 2,3,8 (2005)] (6 patients were included in each block).
During the preparation for colonoscopy each patient are observed for procedure tolerance. On the day of endoscopy, each patient evaluated the degree of the acceptance of the method of bowel cleaning (according to visual analog scale (VAS) and the occurrence of side effects (diary). The endoscopist performing colonoscopy, blinded for the bowel preparation regimen evaluate bowel cleansing and score it, according to the Aronchick and Ottawa scale. The rate of cecum intubation, and the colonoscopy complications (defined as bowel perforation and/or significant bleeding) are analyzed in each bowel preparation group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Polyethylene glycol | Active comparator | Drug: Polyethylene glycolPolyethylene glycol p.o.(Fortrans):60 ml/kg for 2 days |
| PEG + Bisacodyl | Experimental | Drug: polyethylene glycol +BisacodylPolyethylene glycol p.o.(Fortrans): 30 ml/kg for 2 days + Bisacodyl p.o.: 10-15 mg/day |
| Sennosides | Experimental | Drug: SennosidesSennosides: 1tbl/8kg/day for 2 days (1 tbl=8,6 mg sennosides B) |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- children 10 - 18 years of age referred for colonoscopy
- informed consent signed
Key exclusion criteria (2 listed)
- allergy to PEG, sennosides or bisacodyl
- disorders that make oral intake of the preparation impossible (neurological disorders, intestinal obstruction, mental retardation etc.)
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 |
|---|---|---|
| polyethylene glycol +BisacodylAlso: Polyethylene glycol: FortransPolyethylene glycol (Fortrans) p.o. 30 ml/kg/2days + Bisacodyl p.o.10-15 mg/day for 2 days | Drug | PEG + Bisacodyl |
| Polyethylene glycolAlso: Polyethylene glycol: FortransPolyethylene glycol p.o.: 60 ml/kg/days | Drug | Polyethylene glycol |
| SennosidesAlso: Sennosides: XennaSennosides 1tbl/8kg for 2 days | Drug | Sennosides |
Primary outcome
proportions of participants with good or excellent bowel preparation assessed with Ottawa Scale
Time frame: bowel preparation quality with Ottawa scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
According to the Ottawa scale the quality of bowel preparation is estimated by adding points for the cleansing of three parts of colon (descending, transversal and ascending) and points for amount of fluid in the bowel. Score: 0-1 - excellent cleansing, 2-4 - good, 5-7 - sufficient, 8-10 - poor, 11-14 - not appropriate.
proportions of participants with poor/inadequate bowel preparation assessed with Ottawa Scale
Time frame: bowel preparation quality with Ottawa scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
According to the Ottawa scale the quality of bowel preparation is estimated by adding points for the cleansing of three parts of colon (descending, transversal and ascending) and points for amount of fluid in the bowel. Score: 0-1 - excellent cleansing, 2-4 - good, 5-7 - sufficient, 8-10 - poor, 11-14 - not appropriate.
5 secondary outcomes
proportions of participants with very good/good bowel preparation assessed with Aronchick Scale
Time frame: bowel preparation quality with Aronchick scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
proportions of participants with poor/inadequate bowel preparation assessed with Aronchick Scale
Time frame: bowel preparation quality with Aronchick scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
mean bowel preparation score assessed with Ottawa Scale
Time frame: bowel preparation quality with Ottawa scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
mean bowel preparation score assessed with Aronchick scale
Time frame: bowel preparation quality with Aronchick scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
patient satisfaction with the method of preparation assessed with Visual analogue scale (VAS)
Time frame: assessed by patient after completion of bowel preparation regimen before colonoscopy (3rd day of the study)
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 Feb 2012.
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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.
Piotr Dziechciarz, MD study chair
Medical University of Warsaw
Jaroslaw Kierkus, MD principal investigator
Child Health Center
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 polyethylene glycol +Bisacodyl, Polyethylene glycol and Sennosides in people with Colonoscopy Preparation, run by Medical University of Warsaw at 2 sites 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 2 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 Feb 2012. 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 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.
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?
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?
proportions of participants with good or excellent bowel preparation assessed with Ottawa Scale (time frame: bowel preparation quality with Ottawa scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation). 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?
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 Feb 2012.