Clinical trial NCT04456790: Plenvu 1 - Questionnaire Study Exploring Patients Preference in Bowel Preparation Timings for Morning Colonoscopy
Official title: Plenvu 1 - Questionnaire Study Exploring Patients Preference in Bowel Preparation Timings for Morning Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bowel Disease
Lead sponsor: Portsmouth Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2020-07-07
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients attending the endoscopy unit for a flexible sigmoidoscopy or colonoscopy.

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient preferences questionnaire
timeFrame: 3 months
Secondary outcomes:
measure: Patient preferences questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust
state: Wessex
Study officials:
affiliation: Portsmouth NHS Hosptials Trust
name: Joanne Sr Dash
role: PRINCIPAL_INVESTIGATOR
References: