Clinical trial NCT04747665: Experiences and Perceptions of Colonoscopy and New Technologies
Official title: Patient and Endoscopists' Experiences and Perceptions of Colonoscopy and New Technologies in Colonoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bowel Cancer
Colonoscopy
Keywords: Endoscopy
Colonoscopy
Robotic colonoscopy
Artificial intelligence
Patient reported experience
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
First posted: 2021-02-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient invitations will be sent out to those on the emailing list of Crohns and Colitis UK, Bowel Cancer UK, Bowel Research UK and advertised on social media, to target populations likely to have experience in colonoscopy and across a variety of indications. Advertising posters will be placed in the outpatient and endoscopy departments of Leeds Teaching Hospitals NHS Trust.

Endoscopist invitations will be via emailing lists to JAG and ACPGBI members, Gastroenterology trainees and nurse endoscopist groups and advertised on social media, attempting to get a representation of various specialties and roles involved in colonoscopy, such as Gastroenterologists (Consultants and trainees), Surgeons and non-medical endoscopists.

Brief summary: Bowel cancer is the 3rd most common cancer in males and females. Most bowel cancers develop from precancerous polyps in the bowel. Colonoscopy can detect and remove these polyps, thereby reducing the risk of developing bowel cancer. However, colonoscopy is an invasive procedure with inherent risk, and can be both uncomfortable and embarrassing to undergo. The risks and numerous other barriers often mean colonoscopy, and cancer preventing polyp removal, is not performed.

The investigators aim to start the first in-human feasibility clinical investigation of a robotic magnetic colonoscope in 2021. The new device aims to reduce the discomfort and risk associated with colonoscopy. As part of the patient and end user involvement aspect of the project the investigators aim to perform a mixed methodology inductive type research project exploring experiences of colonoscopy for patient and endoscopists.

The study will follow an exploratory mixed methodology format with two parallel work-streams for patients and endoscopists. Each work-stream will consisting of a focus groups (1-2 for each patients and endoscopists), followed by 20 endoscopist and 30 patient in-depth interviews, then an online questionnaire. Each stage will be thematically analysed to form the semi-structured questions for the next stage. The target population will be endoscopists who perform colonoscopy and people who have undergone, or refused to undergo, a colonoscopy. Focus groups will be performed in groups of 6-10 participants, and both interview and focus groups will be performed via video/teleconferencing.


Eligibility criteria: Inclusion Criteria:

One of:

* undergone a colonoscopy
* offered a colonoscopy but declined
* perform or training to perform colonoscopy

Exclusion Criteria:

* Non-English speaking
* Unable to comply with any study requirements
* New or ongoing diagnosis of bowel cancer

Primary outcomes:
measure: Patient participant reported experience of colonoscopy - focus group
timeFrame: 1 year
measure: Patient participant reported experience of colonoscopy - interviews
timeFrame: 1 year
measure: Patient participant reported barriers to colonoscopy - focus group
timeFrame: 1 year
measure: Patient participant reported barriers to colonoscopy - interviews
timeFrame: 1 year
measure: Colonoscopist participant perceptions of the patient experience of colonoscopy - focus group
timeFrame: 1 year
measure: Colonoscopist participant perceptions of the patient experience of colonoscopy - interviews
timeFrame: 1 year
measure: Colonoscopist participant perceptions of the patient barriers to colonoscopy - focus group
timeFrame: 1 year
measure: Colonoscopist participant perceptions of the patient barriers to colonoscopy - interviews
timeFrame: 1 year
measure: PREMs patient participant questionnaire
timeFrame: 1 year
measure: PREMs colonoscopist participant questionnaire
timeFrame: 1 year
Secondary outcomes:
measure: Patient participants thoughts and feelings about robotic colonoscopy - focus group
timeFrame: 1 year
measure: Patient participants thoughts and feelings about robotic colonoscopy - interview
timeFrame: 1 year
measure: Patient participants thoughts and feelings about artificial intelligence - focus group
timeFrame: 1 year
measure: Patient participants thoughts and feelings about artificial intelligence - interviews
timeFrame: 1 year
measure: Colonoscopist participants thoughts and feelings about robotic colonoscopy - focus group
timeFrame: 1 year
measure: Colonoscopist participants thoughts and feelings about robotic colonoscopy - interviews
timeFrame: 1 year
measure: Colonoscopist participants thoughts and feelings about artificial intelligence - focus groups
timeFrame: 1 year
measure: Colonoscopist participants thoughts and feelings about artificial intelligence - interviews
timeFrame: 1 year
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
state: Yorkshire
Study officials:
References: