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Experiences and Perceptions of Colonoscopy and New Technologies

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04747665
Enrollment
100
Registered
2021-02-10
Start date
2021-02-01
Completion date
2021-12-31
Last updated
2021-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Cancer, Colonoscopy

Keywords

Endoscopy, Colonoscopy, Robotic colonoscopy, Artificial intelligence, Patient reported experience

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.

Interventions

OTHERPatient and endoscopist reported experience

Exploration of patient and endoscopists experiences of colonoscopy.

Sponsors

Cancer Research UK
CollaboratorOTHER
The Leeds Teaching Hospitals NHS Trust
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Patient participant reported experience of colonoscopy - focus group1 yearDescriptive reporting on thematic analysis of a focus group involving patients exploring their experience of colonoscopy.
Patient participant reported experience of colonoscopy - interviews1 yearDescriptive reporting on thematic analysis following interviews of patients exploring their experience of colonoscopy.
Patient participant reported barriers to colonoscopy - focus group1 yearDescriptive reporting on thematic analysis following a focus groups involving patients exploring the barriers to colonoscopy.
Patient participant reported barriers to colonoscopy - interviews1 yearDescriptive reporting on thematic analysis following interviews of patients exploring the barriers to colonoscopy.
Colonoscopist participant perceptions of the patient experience of colonoscopy - focus group1 yearDescriptive reporting on thematic analysis of a focus groups involving colonoscopists exploring what they feel to be important patient experience measures in colonoscopy.
Colonoscopist participant perceptions of the patient experience of colonoscopy - interviews1 yearDescriptive reporting on thematic analysis of interviews of colonoscopists exploring what they feel to be important patient experience measures in colonoscopy.
Colonoscopist participant perceptions of the patient barriers to colonoscopy - focus group1 yearDescriptive reporting on thematic analysis of a focus group involving colonoscopists exploring what they feel to be important barriers to colonoscopy for patients.
Colonoscopist participant perceptions of the patient barriers to colonoscopy - interviews1 yearDescriptive reporting on thematic analysis of interviews of colonoscopists exploring what they feel to be important barriers to colonoscopy for patients.
PREMs patient participant questionnaire1 yearLevel of importance given to the reported patient experience measures and barriers (as developed from the interviews and focus groups), assessed by Likert style questions.
PREMs colonoscopist participant questionnaire1 yearPerceived 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.

Secondary

MeasureTime frameDescription
Patient participants thoughts and feelings about robotic colonoscopy - focus group1 yearDescriptive reporting following thematic analysis of a focus group exploring patients' thoughts and feeling on a new colonoscopy technology - a magnetic robotic colonoscope.
Patient participants thoughts and feelings about robotic colonoscopy - interview1 yearDescriptive reporting following thematic analysis of interviews exploring patients' thoughts and feeling on a new colonoscopy technology - a magnetic robotic colonoscope.
Patient participants thoughts and feelings about artificial intelligence - focus group1 yearDescriptive reporting following thematic analysis of a focus group exploring patients' thoughts and feeling on a artificial intelligence in endoscopy
Patient participants thoughts and feelings about artificial intelligence - interviews1 yearDescriptive reporting following thematic analysis of interviews exploring patients' thoughts and feeling on a artificial intelligence in endoscopy
Colonoscopist participants thoughts and feelings about robotic colonoscopy - focus group1 yearDescriptive reporting following thematic analysis of a focus group exploring colonoscopists' thoughts and feeling on a new colonoscopy technology - a magnetic robotic colonoscope.
Colonoscopist participants thoughts and feelings about robotic colonoscopy - interviews1 yearDescriptive reporting following thematic analysis of interviews exploring colonoscopists' thoughts and feeling on a new colonoscopy technology - a magnetic robotic colonoscope.
Colonoscopist participants thoughts and feelings about artificial intelligence - focus groups1 yearDescriptive reporting following thematic analysis of a focus group exploring colonoscopists' thoughts and feeling on a artificial intelligence in endoscopy.
Colonoscopist participants thoughts and feelings about artificial intelligence - interviews1 yearDescriptive reporting following thematic analysis of interviews exploring colonoscopists' thoughts and feeling on a artificial intelligence in endoscopy.

Countries

United Kingdom

Contacts

Primary ContactConchubhair Winters, MBChB
conchubhair.winters@nhs.net07841043502
Backup ContactVenkat Subramanian
V.Subramanian@leeds.ac.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026