Bowel DiseaseNCT04456790
Plenvu 1 - Questionnaire Study Exploring Patients Preference in Bowel Preparation Timings for Morning Colonoscopy
An observational study of Bowel Disease, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Questionnaire study exploring patients preference in bowel preparation timings for morning colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bowel Disease
- How many people
- 304 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jan 2020to 14 Jan 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients attending the endoscopy unit for a flexible sigmoidoscopy or colonoscopy.
Who may be able to join
- • Attending the endoscopy suite at Portsmouth Hospitals NHS Trust for colonoscopy or flexi-sigmoidoscopy procedures
- Aged 18 years and above
- Participant is willing and able to give informed consent for participation in the study
Who cannot join
- • Aged under 18 years
- Unable to complete the questionnaire unsupervised
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospitals NHS Trust
Portsmouth, Wessex, PO6 3LY
About this study
Questionnaire study exploring patients preference in bowel preparation timings for morning colonoscopy.
Read the detailed description
It is often difficult to achieve optimal bowel cleansing for patients having morning colonoscopies. One possible cause of this is the timing of the bowel preparation prior to the procedure. A clean bowel will allow for a clear view of its inner lining which is important for both accurate diagnosis and treatment. Abnormal changes may be tiny, so even the smallest amount of faeces could potentially disguise polyps and cancers.
Additionally, poor bowel cleansing can lead to the procedure being cancelled and repeated on another occasion at a later date, adding to the burden on current resources. Poor bowel preparation has also been shown to be a factor in more difficult and longer procedures, increased patient discomfort, and a higher risk of complications.
This is more of an issue for patients having a colonoscopy in the morning. One cause of this could be the timing of bowel preparation. Studies have shown that having a smaller window of time between finishing bowel preparation and having a colonoscopy results in a much cleaner bowel. The investigators are therefore considering the times patients are required to take their bowel preparation in order to improve the bowel cleansing outcome for a morning colonoscopy.
Previous studies have indicated that a split dose (one evening dose and one early morning dose) improves bowel cleansing compared to all doses taken the day prior to colonoscopy. However, there has been no research to assess the efficacy of early morning bowel preparation and its acceptability to patients. This information may lead to future studies and in order to ensure the success of this further research it is important to understand any potential barriers from patients to new timing regimens.
Therefore, such information as highest education level, employment status, age and experience of previous bowel preparation for colonoscopy for the patient population is captured.
Results from previous studies looking at potential barriers have shown that such issues as having a simplified colonoscopy instruction sheet improved bowel preparation and lowered cancellation rates and that patients with a history of colonoscopy are less likely to follow bowel preparation instructions and therefore achieve adequate bowel cleansing.
A total of 300 participants will be approached; 150 participants who have previously had bowel preparation for colonoscopy and 150 participants who have not, and are attending for a flexi sigmoidoscopy and therefore may have to go on to have a colonoscopy.
These groups will be further split to half attending in the morning and half attending in the afternoon, thus achieving a cross section of this patient group.
- Conditions
- Bowel Disease
- Medical subject headings
- Intestinal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient preferences questionnaire
Patients to rate their preference for timings from 1st to third choice.
Measured: 3 months
Secondary outcomes (1)
Patient preferences questionnaire
To establish the reasons for expressed preferences for bowel preparation timings
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start25 Jan 2020
- Primary completion14 Jan 2021
- Study completion14 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel DiseaseStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Joanne Sr Dash, Principal investigator, Portsmouth NHS Hosptials Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456790
- Sponsor's protocol ID
- PHT/2019/32
- Status last verified
- Mar 2021
- First submitted
- 19 Feb 2020
- Last updated
- 16 Mar 2021
- 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 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plenvu 1 - Questionnaire Study Exploring Patients Preference in Bowel Preparation Timings for Morning Colonoscopy
- ClinicalTrials.gov ID
- NCT04456790
- Acronym / sponsor ID
- PHT/2019/32
- Conditions
- Bowel Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- 25 Jan 2020 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 7 Jul 2020 (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.
Questionnaire study exploring patients preference in bowel preparation timings for morning colonoscopy.
Detailed description
It is often difficult to achieve optimal bowel cleansing for patients having morning colonoscopies. One possible cause of this is the timing of the bowel preparation prior to the procedure. A clean bowel will allow for a clear view of its inner lining which is important for both accurate diagnosis and treatment. Abnormal changes may be tiny, so even the smallest amount of faeces could potentially disguise polyps and cancers.
Additionally, poor bowel cleansing can lead to the procedure being cancelled and repeated on another occasion at a later date, adding to the burden on current resources. Poor bowel preparation has also been shown to be a factor in more difficult and longer procedures, increased patient discomfort, and a higher risk of complications.
This is more of an issue for patients having a colonoscopy in the morning. One cause of this could be the timing of bowel preparation. Studies have shown that having a smaller window of time between finishing bowel preparation and having a colonoscopy results in a much cleaner bowel. The investigators are therefore considering the times patients are required to take their bowel preparation in order to improve the bowel cleansing outcome for a morning colonoscopy.
Previous studies have indicated that a split dose (one evening dose and one early morning dose) improves bowel cleansing compared to all doses taken the day prior to colonoscopy. However, there has been no research to assess the efficacy of early morning bowel preparation and its acceptability to patients. This information may lead to future studies and in order to ensure the success of this further research it is important to understand any potential barriers from patients to new timing regimens.
Therefore, such information as highest education level, employment status, age and experience of previous bowel preparation for colonoscopy for the patient population is captured.
Results from previous studies looking at potential barriers have shown that such issues as having a simplified colonoscopy instruction sheet improved bowel preparation and lowered cancellation rates and that patients with a history of colonoscopy are less likely to follow bowel preparation instructions and therefore achieve adequate bowel cleansing.
A total of 300 participants will be approached; 150 participants who have previously had bowel preparation for colonoscopy and 150 participants who have not, and are attending for a flexi sigmoidoscopy and therefore may have to go on to have a colonoscopy.
These groups will be further split to half attending in the morning and half attending in the afternoon, thus achieving a cross section of this patient group.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients attending the endoscopy unit for a flexible sigmoidoscopy or colonoscopy.
Key inclusion criteria (3 listed)
- • Attending the endoscopy suite at Portsmouth Hospitals NHS Trust for colonoscopy or flexi-sigmoidoscopy procedures
Key exclusion criteria (2 listed)
- • Aged under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient preferences questionnaire
Time frame: 3 months
Patients to rate their preference for timings from 1st to third choice.
1 secondary outcome
Patient preferences questionnaire
Time frame: 3 months
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 16 Mar 2021.
- 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.
Joanne Sr Dash principal investigator
Portsmouth NHS Hosptials Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Disease, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
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 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 16 Mar 2021. 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 United Kingdom. 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 preferences questionnaire (time frame: 3 months). 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 16 Mar 2021.