Experiences and Perceptions of Colonoscopy and New Technologies

Colonoscopy Clinical Trial

Official title:

Patient and Endoscopists' Experiences and Perceptions of Colonoscopy and New Technologies in Colonoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04747665
• Other study ID #: IRAS 281674
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2021
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: Conchubhair Winters, MBChB
• Phone: 07841043502
• Email: conchubhair.winters[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bowel Cancer
• Colonoscopy

Intervention

Other:
• Patient and endoscopist reported experience
Exploration of patient and endoscopists experiences of colonoscopy.

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds	Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
The Leeds Teaching Hospitals NHS Trust	Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient participant reported experience of colonoscopy - focus group	Descriptive reporting on thematic analysis of a focus group involving patients exploring their experience of colonoscopy.	1 year
Primary	Patient participant reported experience of colonoscopy - interviews	Descriptive reporting on thematic analysis following interviews of patients exploring their experience of colonoscopy.	1 year
Primary	Patient participant reported barriers to colonoscopy - focus group	Descriptive reporting on thematic analysis following a focus groups involving patients exploring the barriers to colonoscopy.	1 year
Primary	Patient participant reported barriers to colonoscopy - interviews	Descriptive reporting on thematic analysis following interviews of patients exploring the barriers to colonoscopy.	1 year
Primary	Colonoscopist participant perceptions of the patient experience of colonoscopy - focus group	Descriptive reporting on thematic analysis of a focus groups involving colonoscopists exploring what they feel to be important patient experience measures in colonoscopy.	1 year
Primary	Colonoscopist participant perceptions of the patient experience of colonoscopy - interviews	Descriptive reporting on thematic analysis of interviews of colonoscopists exploring what they feel to be important patient experience measures in colonoscopy.	1 year
Primary	Colonoscopist participant perceptions of the patient barriers to colonoscopy - focus group	Descriptive reporting on thematic analysis of a focus group involving colonoscopists exploring what they feel to be important barriers to colonoscopy for patients.	1 year
Primary	Colonoscopist participant perceptions of the patient barriers to colonoscopy - interviews	Descriptive reporting on thematic analysis of interviews of colonoscopists exploring what they feel to be important barriers to colonoscopy for patients.	1 year
Primary	PREMs patient participant questionnaire	Level of importance given to the reported patient experience measures and barriers (as developed from the interviews and focus groups), assessed by Likert style questions.	1 year
Primary	PREMs colonoscopist participant questionnaire	Perceived level of importance given to the reported patient experience measures and barriers (as developed from the interviews and focus groups), assessed by Likert style questions.	1 year
Secondary	Patient participants thoughts and feelings about robotic colonoscopy - focus group	Descriptive reporting following thematic analysis of a focus group exploring patients' thoughts and feeling on a new colonoscopy technology - a magnetic robotic colonoscope.	1 year
Secondary	Patient participants thoughts and feelings about robotic colonoscopy - interview	Descriptive reporting following thematic analysis of interviews exploring patients' thoughts and feeling on a new colonoscopy technology - a magnetic robotic colonoscope.	1 year
Secondary	Patient participants thoughts and feelings about artificial intelligence - focus group	Descriptive reporting following thematic analysis of a focus group exploring patients' thoughts and feeling on a artificial intelligence in endoscopy	1 year
Secondary	Patient participants thoughts and feelings about artificial intelligence - interviews	Descriptive reporting following thematic analysis of interviews exploring patients' thoughts and feeling on a artificial intelligence in endoscopy	1 year
Secondary	Colonoscopist participants thoughts and feelings about robotic colonoscopy - focus group	Descriptive reporting following thematic analysis of a focus group exploring colonoscopists' thoughts and feeling on a new colonoscopy technology - a magnetic robotic colonoscope.	1 year
Secondary	Colonoscopist participants thoughts and feelings about robotic colonoscopy - interviews	Descriptive reporting following thematic analysis of interviews exploring colonoscopists' thoughts and feeling on a new colonoscopy technology - a magnetic robotic colonoscope.	1 year
Secondary	Colonoscopist participants thoughts and feelings about artificial intelligence - focus groups	Descriptive reporting following thematic analysis of a focus group exploring colonoscopists' thoughts and feeling on a artificial intelligence in endoscopy.	1 year
Secondary	Colonoscopist participants thoughts and feelings about artificial intelligence - interviews	Descriptive reporting following thematic analysis of interviews exploring colonoscopists' thoughts and feeling on a artificial intelligence in endoscopy.	1 year