Experiences and Perceptions of Colonoscopy and New Technologies

The Leeds Teaching Hospitals NHS Trust

Status: Unknown

Conditions: Colonoscopy; Bowel Cancer

Treatments: Other: Patient and endoscopist reported experience

Study type: Observational

Funder types: Other

Identifiers

NCT04747665

IRAS 281674

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Patients

Description:

Patients who have undergone or refused to undergo colonoscopy

Treatment:

Other: Patient and endoscopist reported experience

Endoscopists

Description:

Endoscopists who perform or are training to perform colonoscopy

Treatment:

Other: Patient and endoscopist reported experience