- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04456790
Plenvu 1 - Questionnaire Study Exploring Patients Preference in Bowel Preparation Timings for Morning Colonoscopy
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Wessex
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Portsmouth, Wessex, United Kingdom, PO6 3LY
- Portsmouth Hospitals NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
• 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
Exclusion Criteria:
• Aged under 18 years
- Unable to complete the questionnaire unsupervised
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient preferences questionnaire
Time Frame: 3 months
|
Patients to rate their preference for timings from 1st to third choice.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient preferences questionnaire
Time Frame: 3 months
|
To establish the reasons for expressed preferences for bowel preparation timings
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joanne Sr Dash, Portsmouth NHS Hosptials Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHT/2019/32
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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