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| Name | Class |
|---|---|
| Cancer Research UK | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Patients who have undergone or refused to undergo colonoscopy |
| |
| Endoscopists | Endoscopists who perform or are training to perform colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient and endoscopist reported experience | Other | Exploration of patient and endoscopists experiences of colonoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patient participant reported experience of colonoscopy - interviews | Descriptive reporting on thematic analysis following interviews of patients exploring their experience of colonoscopy. | 1 year |
| 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 |
| Patient participant reported barriers to colonoscopy - interviews | Descriptive reporting on thematic analysis following interviews of patients exploring the barriers to colonoscopy. | 1 year |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patient participants thoughts and feelings about robotic colonoscopy - interview |
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Inclusion Criteria:
One of:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Conchubhair Winters, MBChB | Contact | 07841043502 | conchubhair.winters@nhs.net | |
| Venkat Subramanian | Contact | V.Subramanian@leeds.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leeds Teaching Hospitals NHS Trust | Recruiting | Leeds | Yorkshire | LS9 7TF | United Kingdom |
If possible to suitably anonymise, exerts from the focus group and interview transcripts will be made available.
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| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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 |
| 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 |
| 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 |
| 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 |
Descriptive reporting following thematic analysis of interviews exploring patients' thoughts and feeling on a new colonoscopy technology - a magnetic robotic colonoscope. |
| 1 year |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |