Plenvu 1 - Questionnaire Study Exploring Patients Preference in Bowel Preparation Timings for Morning Colonoscopy

Questionnaire study exploring patients preference in bowel preparation timings for morning colonoscopy.

Study Overview

• Status: Completed
• Conditions: Bowel Disease

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: Observational
• Enrollment (Actual): 304

Contacts and Locations

Study Locations

• United Kingdom
  • Wessex
    • Portsmouth, Wessex, United Kingdom, PO6 3LY
      • Portsmouth Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients attending the endoscopy unit for a flexible sigmoidoscopy or colonoscopy.

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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient preferences questionnaire	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	To establish the reasons for expressed preferences for bowel preparation timings	3 months

Collaborators and Investigators

• Sponsor: Portsmouth Hospitals NHS Trust
• Investigators: Principal Investigator: Joanne Sr Dash, Portsmouth NHS Hosptials Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2020
• Primary Completion (Actual): January 14, 2021
• Study Completion (Actual): January 14, 2021

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases
• Other Study ID Numbers: PHT/2019/32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No