Minimally Invasive SurgeryNCT06385210
Barriers to Routine Surgical Video Recording
A study testing Semi structured interviews in people with Minimally Invasive Surgery and Laparoscopic Surgery, run by Imperial College London at 1 site in United Kingdom.
Trial summary
In order to improve the implementation of routine surgical video recording, the researchers want to understand what the challenges associated with the uptake of this technology are. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Minimally Invasive Surgery, Laparoscopic Surgery
- What is being tested?
- Semi structured interviews
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2024to 24 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Work within the wider surgical care team or in the governance of surgical video or in surgical industry
- Available to online facilities
- Explicitly consented Able to understand and communicate in English
- Inclusion criteria for patient participants will be as follows:
- Aged 18
- On a waiting list for surgery or have previously undergone surgery in the past 3 years
- Access to online (Teams) facilities
- Explicitly consented Able to understand and communicate in English
Who cannot join
- Vulnerable adult
- Did not consent to participate
- Not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Barriers to Surgical Video Recording: a Qualitative Study
In order to improve the implementation of routine surgical video recording, the researchers want to understand what the challenges associated with the uptake of this technology are. The aim of this study is to explore the barriers faced by key stakeholders including the surgical care team, information governance, and patients within the field of surgical video reporting. The data from this qualitative study will allow the researchers to understand better the challenges associated with uptake of surgical video recording. This will allow the researchers to develop strategies to overcome these challenges and subsequently improve uptake of surgical video recording which will promote safer and more transparent surgery.
Read the detailed description
This study will involve the use of interviews to determine the barriers to the implementation of surgical video recording.
Participants will be invited to participate in an online 1 on 1 interview 1 on 1. A total of 10-15 participants will be recruited to interview. Interview guides have been developed from the existing literature on the subject. A member of the research team will be present to conduct all interviews. It is estimated that interviews will last between 45-60mins. All interview audio and video will be recorded, as appropriate.
The aim is to recruit 15 participants of which 2-3 will be patient participants and the remaining will be professional participants.
Concerning recruitment of surgical team members: surgeons; trainees; anaesthetists; nursing staff; and operating department practitioners will be invited to participate. Members of the trust's information governance team will also be recruited as key stakeholders within this field as well as representatives from industry who are known personally to the study team.
Non-patient participants will be identified according to their role and be approached directly in person by a member of the study team at their place of work eg outpatient clinic or operating theatres or invited via email for the purposes of recruitment.
Concerning recruitment of patients, appropriate surgical patients satisfying the study inclusion and exclusion criteria will be identified by the direct care team in an outpatient setting through review of patient records. These patients will be under the direct clinical care of members of the study team and will be patients who are awaiting or have recently undergone surgery. The direct care team will explain the rationale of the study and if the potential participant is willing to be contacted, the direct care team will obtain an email address from the potential participant. The potential participant's email address will then be passed on to the study team for further contact.
All interested participants will be emailed a link to an online participant information sheet and consent form.
- Conditions
- Minimally Invasive Surgery, Laparoscopic Surgery
- Being tested
- Semi structured interviews
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi structured interviewsOther
Participants will be interviewed concerning perceived barriers to routine surgical video recording
| Study group | Role | What they receive |
|---|---|---|
| Semi structured interviews | Experimental | Semi-structured interviews with topic guides centred around the Non adoption, abandonment, scale-up, spread, and sustainability (NASSS) framework will be led by a member of the research team and conducted with all participants. The aim of the interviews is to explore perceived barriers to the uptake of routine surgical video recording. Transcripts will be subsequently thematically analysed using an inductive approach to determine key themes to the barriers of routine surgical video recording. Receives: Other: Semi structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stakeholder perceived barriers to surgical video recording
Participants will undergo a semi-structured interview with topic guides centred around the Non adoption, abandonment, scale-up, spread, and sustainability (NASSS) framework. Interview audio files will be subsequently transcribed and an inductive thematic analysis will be conducted using a grounded-theory approach in order to elucidate key themes to perceived barriers to the uptake of routine surgical video recording.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Apr 2024
- Primary completion24 Apr 2024
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimally Invasive SurgeryStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385210
- Sponsor's protocol ID
- 22SM7855
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Datasets generated will be available upon reasonable request to the study lead.
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Barriers to Surgical Video Recording: a Qualitative Study
- ClinicalTrials.gov ID
- NCT06385210
- Acronym / sponsor ID
- 22SM7855
- Conditions
- Minimally Invasive Surgery, Laparoscopic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In order to improve the implementation of routine surgical video recording, the researchers want to understand what the challenges associated with the uptake of this technology are. The aim of this study is to explore the barriers faced by key stakeholders including the surgical care team, information governance, and patients within the field of surgical video reporting. The data from this qualitative study will allow the researchers to understand better the challenges associated with uptake of surgical video recording. This will allow the researchers to develop strategies to overcome these challenges and subsequently improve uptake of surgical video recording which will promote safer and more transparent surgery.
Detailed description
This study will involve the use of interviews to determine the barriers to the implementation of surgical video recording.
Participants will be invited to participate in an online 1 on 1 interview 1 on 1. A total of 10-15 participants will be recruited to interview. Interview guides have been developed from the existing literature on the subject. A member of the research team will be present to conduct all interviews. It is estimated that interviews will last between 45-60mins. All interview audio and video will be recorded, as appropriate.
The aim is to recruit 15 participants of which 2-3 will be patient participants and the remaining will be professional participants.
Concerning recruitment of surgical team members: surgeons; trainees; anaesthetists; nursing staff; and operating department practitioners will be invited to participate. Members of the trust's information governance team will also be recruited as key stakeholders within this field as well as representatives from industry who are known personally to the study team.
Non-patient participants will be identified according to their role and be approached directly in person by a member of the study team at their place of work eg outpatient clinic or operating theatres or invited via email for the purposes of recruitment.
Concerning recruitment of patients, appropriate surgical patients satisfying the study inclusion and exclusion criteria will be identified by the direct care team in an outpatient setting through review of patient records. These patients will be under the direct clinical care of members of the study team and will be patients who are awaiting or have recently undergone surgery. The direct care team will explain the rationale of the study and if the potential participant is willing to be contacted, the direct care team will obtain an email address from the potential participant. The potential participant's email address will then be passed on to the study team for further contact.
All interested participants will be emailed a link to an online participant information sheet and consent form.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semi structured interviews | Experimental | Other: Semi structured interviewsSemi-structured interviews with topic guides centred around the Non adoption, abandonment, scale-up, spread, and sustainability (NASSS) framework will be led by a member of the research team and conducted with all participants. The aim of the interviews is to explore perceived barriers to the uptake of routine surgical video recording. Transcripts will be subsequently thematically analysed using an inductive approach to determine key themes to the barriers of routine surgical video recording. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18
- On a waiting list for surgery or have previously undergone surgery in the past 3 years
- Access to online (Teams) facilities
- Explicitly consented Able to understand and communicate in English
Key exclusion criteria (3 listed)
- Vulnerable adult
- Did not consent to participate
- Not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi structured interviewsParticipants will be interviewed concerning perceived barriers to routine surgical video recording | Other | Semi structured interviews |
Primary outcome
Stakeholder perceived barriers to surgical video recording
Time frame: 6 months
Participants will undergo a semi-structured interview with topic guides centred around the Non adoption, abandonment, scale-up, spread, and sustainability (NASSS) framework. Interview audio files will be subsequently transcribed and an inductive thematic analysis will be conducted using a grounded-theory approach in order to elucidate key themes to perceived barriers to the uptake of routine surgical video recording.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: Yes. Datasets generated will be available upon reasonable request to the study lead.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi structured interviews in people with Minimally Invasive Surgery and Laparoscopic Surgery, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stakeholder perceived barriers to surgical video recording (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.