Experiences and Perceptions of Colonoscopy and New Technologies

NCT ID: NCT04747665

Last Updated: 2021-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bowel Cancer Colonoscopy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients

Patients who have undergone or refused to undergo colonoscopy

Patient and endoscopist reported experience

Intervention Type OTHER

Exploration of patient and endoscopists experiences of colonoscopy.

Endoscopists

Endoscopists who perform or are training to perform colonoscopy

Patient and endoscopist reported experience

Intervention Type OTHER

Exploration of patient and endoscopists experiences of colonoscopy.

Interventions

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Patient and endoscopist reported experience

Exploration of patient and endoscopists experiences of colonoscopy.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cancer Research UK

OTHER

Sponsor Role collaborator

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Leeds Teaching Hospitals NHS Trust

Leeds, Yorkshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Conchubhair Winters, MBChB

Role: CONTACT

07841043502

Venkat Subramanian

Role: CONTACT

Facility Contacts

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Conchubhair Winters

Role: primary

07841043502

Venkat Subramanian

Role: backup

Other Identifiers

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IRAS 281674

Identifier Type: -

Identifier Source: org_study_id

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