Patient Satisfaction and Efficacy of Bowel-preparationNCT05192551
Patient Satisfaction and Efficacy of Different PEG-based Bowel Preparations- an Observational Study
An observational study of Patient Satisfaction and Efficacy of Bowel-preparation, run by Karolinska Institutet at 5 sites in Sweden.
Trial summary
An multi-center, observational study where we compare the current standard, PEG-based bowel-prep to a (in Sweden) recently approved and introduced low volume (1 litre) PEG-based bowel-prep (Plenvu) in a clinical routine situation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Satisfaction and Efficacy of Bowel-preparation
- What is being tested?
- Bowel-prep (Plenvu as experimental arm)
- How many people
- 1,000 participants
- Where
- 5 sitesSweden
- Study dates
- 1 Apr 2021to 15 Nov 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that are scheduled for a routine colonoscopy at the endoscopy unit
Who may be able to join
- All patients over 18 admitted for colonoscopy at the participating endoscopy-units.
Who cannot join
- Renal failure or other contraindication for using low-dose bowel-preps
- not speking or reading swedish
- Need for a translator
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites
Universitetssjukhuset Linköping
Linköping, 58185
Skåne Universitetssjukhus
Malmö, 21428
Universitetssjukhuset Örebro
Örebro, 701 85
Aleris GastromottagningenCity
Stockholm, 11137
Ersta sjukhus
Stockholm, 11628
About this study
Official title: Comparison of Patient Satisfaction and Efficacy of Different PEG-based Bowel Preparations- an Observational Study in Five Endoscopy Units in Sweden
An multi-center, observational study where we compare the current standard, PEG-based bowel-prep to a (in Sweden) recently approved and introduced low volume (1 litre) PEG-based bowel-prep (Plenvu) in a clinical routine situation.
The investigators will investigate if there are any differences in patient satisfaction and efficacy of the different bowel preparations
Read the detailed description
When performing Colonoscopy it is essential to use a bowel-prep that is highly effective and at the same time tolerable to intake for the patient to ensure that the patients intakes the recommended amount of the bowel-prep.
This in order to be able to detect pathological findings in the mucosa. Currently in n Sweden the standard bowel-prep used in most endoscopy-units is high volume bowel preps (4 litres) in split dose. It can be difficult for the patient to intake the whole dose wish can lead to a sub-optimal bowel-cleansing.
Recently, in Sweden, a new low-volume bowel-prep has been approved and introduced (Plenvu).
This preparation, totally 1 litre of bowel prep given in a split dose is potentially easier for the patient to intake but it is essentially to ensure that the efficacy i at least as good as the current high dose preparation. In this study the investigators will therefore investigate patient satisfaction and efficacy of the different bowel preparations, comparing Plenvu with the current standard bowel-prep regime at the participating endoscopy units.
Five endoscopy units participates in this study (Endoskopi City, Stockholm, Endoskopienheten i Malmö, Endoskopienheten i Linköping, Endoskopienheten i Örebro, Endoskopienheten Ersta sjukhus, Stockholm).
In each endoscopy unit 100 consecutive patients will be prescribed Plenvu and another 100 consecutive patients will be prescribed the current standard bowel-prep at the actual unit. a total of 1000 patients will participate in the study.
The currently used bowel-preps at the different endoscopy units are: Vistaprep, Laxabon and Movprep This is a study performed in a clinical context and no randomization is made. When arriving to the endoscopy unit patients are asked to participate in the study and if willing to participate patients will sign an informed consent-form.
Before the colonoscopy the patients fills in a questionnaire about the bowel-prep experience concerning; smell, taste, overall experience (five graded scales) of the prep. In the questionnaire patients are also asked how much of the prescribed bowel-prep that have been digested and how much extra fluid the patient have been drinking during the preparation process. The patients are also asked about if they have been experienced nausea or been vomiting.
After the colonoscopy, the gastroenterologist performing the endoscopy fills in the Boston Bowel Preparation Scale (BBPS) as a measure of how successful the bowel cleansing has been.
Based on this information the investigators will compare patient satisfaction and efficacy of the bowel-cleansing in the group that has been prescribed Plenvu to the group that has been prescribed the endoscopy-units standard bowel-prep
- Being tested
- Bowel-prep (Plenvu as experimental arm)
- Keywords
- Bowel-prep, Colonoscopy, Patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bowel-prep (Plenvu as experimental arm)Other
Also called Laxabon,, Vistaprep, Movprep
In this study we will investigate the efficacy and patient satisfaction of the,in Sweden recently approved and introduced low-dose, Peg-based bowel-prep Plenvu in comparsion with the standard bowel-preps used i today's clinical routine
| Study group | Role | What they receive |
|---|---|---|
| Plenvu | A new type of low-volume bowel-prep recently approved and introduced in the Swedish market. The dose is 500 ml x 2, The first dose is given the evening before the colonoscopy and the second dose is given 4-5 hours before the colonoscopy. Receives: Other: Bowel-prep (Plenvu as experimental arm) | |
| Laxabon | A standard high volume bowel-prep, used for a long time in Sweden. The dose is 2000 ml x 2. The first dose is given the evening before the colonoscopy and the second dose is given 4-5 hours before the colonoscopy. Receives: Other: Bowel-prep (Plenvu as experimental arm) | |
| Vistaprep | A standard high volume bowel-prep, used for a long time in Sweden. The dose is 2000 ml x 2. The first dose is given the evening before the colonoscopy and the second dose is given 4-5 hours before the colonoscopy. Receives: Other: Bowel-prep (Plenvu as experimental arm) | |
| Movprep | A standard median volume bowel-prep, used for a long time in Sweden. The dose is 1000 ml x 2. The first dose is given the evening before the colonoscopy and the second dose is given 4-5 hours before the colonoscopy. Receives: Other: Bowel-prep (Plenvu as experimental arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with bowel prep
When arriving to the endoscopy unit the patients fills in a questionnaire about their bowel-prep experience concerning; smell, taste, overall experience (five graded scales) of the prep. The higher the number are the more satisfied the patient are with the current experience (smell, taste and overall experience.
In the questionnaire they are also asked how much of the prescribed bowel-prep they have digested and how much extra fluid they have been drinking during the preparation process (0-4 litres).
Measured: Day 1,When arriving to the endoscopy unit, Immediately before the endoscopy
Efficacy of the bowel prep
Immediately after the colonoscopy the gastroenterologist who has performed the investigation fills in the Boston Bowel Preparation Scale,a widely used scale describing how clean the bowel is in each of the three segment ant in total. Each segment is graded form 0-3 (3 perfect cleaning) and a sum-score of 0-9 (9 perfect clening) is calculated. The higher the number the better the cleansing are
Measured: Day 1,Directly after the colonoscopy,
Secondary outcomes (1)
Differences in the reported frequency of nausea and vomiting during the bowel-preparation process
The patients are asked if they have been experienced nausea or been vomiting (yes /no)
Measured: Day 1,When arriving to the endoscopy unit, Immediately before the endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start1 Apr 2021
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Satisfaction and Efficacy of Bowel-preparationStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Perjohan Lindfors, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192551
- Sponsor's protocol ID
- Bowelprep
- Status last verified
- Jul 2022
- First submitted
- 7 Dec 2021
- Last updated
- 8 Jul 2022
- 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 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patient Satisfaction and Efficacy of Different PEG-based Bowel Preparations- an Observational Study in Five Endoscopy Units in Sweden
- ClinicalTrials.gov ID
- NCT05192551
- Acronym / sponsor ID
- Bowelprep
- Keywords
- Bowel-prep, Colonoscopy, Patient satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 14 Jan 2022 (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.
An multi-center, observational study where we compare the current standard, PEG-based bowel-prep to a (in Sweden) recently approved and introduced low volume (1 litre) PEG-based bowel-prep (Plenvu) in a clinical routine situation.
The investigators will investigate if there are any differences in patient satisfaction and efficacy of the different bowel preparations
Detailed description
When performing Colonoscopy it is essential to use a bowel-prep that is highly effective and at the same time tolerable to intake for the patient to ensure that the patients intakes the recommended amount of the bowel-prep.
This in order to be able to detect pathological findings in the mucosa. Currently in n Sweden the standard bowel-prep used in most endoscopy-units is high volume bowel preps (4 litres) in split dose. It can be difficult for the patient to intake the whole dose wish can lead to a sub-optimal bowel-cleansing.
Recently, in Sweden, a new low-volume bowel-prep has been approved and introduced (Plenvu).
This preparation, totally 1 litre of bowel prep given in a split dose is potentially easier for the patient to intake but it is essentially to ensure that the efficacy i at least as good as the current high dose preparation. In this study the investigators will therefore investigate patient satisfaction and efficacy of the different bowel preparations, comparing Plenvu with the current standard bowel-prep regime at the participating endoscopy units.
Five endoscopy units participates in this study (Endoskopi City, Stockholm, Endoskopienheten i Malmö, Endoskopienheten i Linköping, Endoskopienheten i Örebro, Endoskopienheten Ersta sjukhus, Stockholm).
In each endoscopy unit 100 consecutive patients will be prescribed Plenvu and another 100 consecutive patients will be prescribed the current standard bowel-prep at the actual unit. a total of 1000 patients will participate in the study.
The currently used bowel-preps at the different endoscopy units are: Vistaprep, Laxabon and Movprep This is a study performed in a clinical context and no randomization is made. When arriving to the endoscopy unit patients are asked to participate in the study and if willing to participate patients will sign an informed consent-form.
Before the colonoscopy the patients fills in a questionnaire about the bowel-prep experience concerning; smell, taste, overall experience (five graded scales) of the prep. In the questionnaire patients are also asked how much of the prescribed bowel-prep that have been digested and how much extra fluid the patient have been drinking during the preparation process. The patients are also asked about if they have been experienced nausea or been vomiting.
After the colonoscopy, the gastroenterologist performing the endoscopy fills in the Boston Bowel Preparation Scale (BBPS) as a measure of how successful the bowel cleansing has been.
Based on this information the investigators will compare patient satisfaction and efficacy of the bowel-cleansing in the group that has been prescribed Plenvu to the group that has been prescribed the endoscopy-units standard bowel-prep
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Plenvu | – | Other: Bowel-prep (Plenvu as experimental arm)A new type of low-volume bowel-prep recently approved and introduced in the Swedish market. The dose is 500 ml x 2, The first dose is given the evening before the colonoscopy and the second dose is given 4-5 hours before the colonoscopy. |
| Laxabon | – | Other: Bowel-prep (Plenvu as experimental arm)A standard high volume bowel-prep, used for a long time in Sweden. The dose is 2000 ml x 2. The first dose is given the evening before the colonoscopy and the second dose is given 4-5 hours before the colonoscopy. |
| Vistaprep | – | Other: Bowel-prep (Plenvu as experimental arm)A standard high volume bowel-prep, used for a long time in Sweden. The dose is 2000 ml x 2. The first dose is given the evening before the colonoscopy and the second dose is given 4-5 hours before the colonoscopy. |
| Movprep | – | Other: Bowel-prep (Plenvu as experimental arm)A standard median volume bowel-prep, used for a long time in Sweden. The dose is 1000 ml x 2. The first dose is given the evening before the colonoscopy and the second dose is given 4-5 hours before the colonoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that are scheduled for a routine colonoscopy at the endoscopy unit
Key inclusion criteria (1 listed)
- All patients over 18 admitted for colonoscopy at the participating endoscopy-units.
Key exclusion criteria (3 listed)
- Renal failure or other contraindication for using low-dose bowel-preps
- not speking or reading swedish
- Need for a translator
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 |
|---|---|---|
| Bowel-prep (Plenvu as experimental arm)Also: Laxabon,, Vistaprep, MovprepIn this study we will investigate the efficacy and patient satisfaction of the,in Sweden recently approved and introduced low-dose, Peg-based bowel-prep Plenvu in comparsion with the standard bowel-preps used i today's clinical routine | Other | Laxabon, Movprep, Plenvu, Vistaprep |
Primary outcome
Patient satisfaction with bowel prep
Time frame: Day 1,When arriving to the endoscopy unit, Immediately before the endoscopy
When arriving to the endoscopy unit the patients fills in a questionnaire about their bowel-prep experience concerning; smell, taste, overall experience (five graded scales) of the prep. The higher the number are the more satisfied the patient are with the current experience (smell, taste and overall experience. In the questionnaire they are also asked how much of the prescribed bowel-prep they have digested and how much extra fluid they have been drinking during the preparation process (0-4 litres).
Efficacy of the bowel prep
Time frame: Day 1,Directly after the colonoscopy,
Immediately after the colonoscopy the gastroenterologist who has performed the investigation fills in the Boston Bowel Preparation Scale,a widely used scale describing how clean the bowel is in each of the three segment ant in total. Each segment is graded form 0-3 (3 perfect cleaning) and a sum-score of 0-9 (9 perfect clening) is calculated. The higher the number the better the cleansing are
1 secondary outcome
Differences in the reported frequency of nausea and vomiting during the bowel-preparation process
Time frame: Day 1,When arriving to the endoscopy unit, Immediately before the endoscopy
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 8 Jul 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Satisfaction and Efficacy of Bowel-preparation, run by Karolinska Institutet at 5 sites in Sweden.
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 3 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 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. 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?
Patient satisfaction with bowel prep (time frame: Day 1,When arriving to the endoscopy unit, Immediately before the endoscopy). 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 8 Jul 2022.