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Bladder CancerNCT06152666

Day-case Endourology; Enablers, Barriers, Unexpected Outcomes

An observational study of Bladder Cancer and Bladder Outlet Obstruction, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A qualitative research study conducted in hospitals across England, in which staff members will be interviewed. We will interview staff who are directly or indirectly involved in delivering care for patients undergoing the operations of interest; namely bladder tumour resection, prostate resection or enucleation, and… Read more about this study

Who is it for?
Any age
What is being tested?
None - qualitative interviews
How many people
15 participants
Where
1 siteUnited Kingdom
Study dates
1 Dec 2023to 1 Oct 2024
Phase
Observational
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 Any age
  • All sexes
  • Child, Adult, Older adult

Study population: Any of the following staff members from across a range of urology units: * Consultant and trainee urologists * Anaesthetists * Theatre nursing staff and healthcare assistants * Day-case unit nursing staff * Inpatient ward nursing staff * Cancer nurse specialists * Urology managers * Urology department clinical leads

Who may be able to join

  • Staff members who are routinely involved, either directly or indirectly, in the delivery of any of TURBT, TURP, TUEP, URS within NHS hospitals.
  • Willing and able to provide informed consent

Who cannot join

  • Staff who are not regularly involved in any of TURBT, TURP, TUEP or URS, defined as being involved in the operation less than 10 cases per year.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site, 1 recruiting
  • Royal Devon University Healthcare NHS Foundation Trust

    Exeter, Devon, EX5 4EH

    Joseph B John, BSc, MBBS, +441392411611, joseph.john3@nhs.net

    John S McGrath, MBBS, MD, +441392411611, john.mcgrath4@nhs.net

    Recruiting

Other trials in United Kingdom

About this study

Official title: Understanding Enablers, Barriers, and Unexpected Outcomes Associated With Adoption of Routine Day-case Surgery Pathways for Common Endourology Operations: Qualitative Interviews With Healthcare Professionals.

A qualitative research study conducted in hospitals across England, in which staff members will be interviewed. We will interview staff who are directly or indirectly involved in delivering care for patients undergoing the operations of interest; namely bladder tumour resection, prostate resection or enucleation, and ureteroscopy for upper urinary tract stones. We hope to find out the reasons why some hospitals can perform day-case surgery with very high rates, and why others do not. We also hope to find out about any unexpected outcomes observed when performing day-case surgery for the operations of interest.

Staff working in a range of different hospitals from across England with varying day-case rates will be interviewed. Hospitals in large city and more rural areas will be assessed. Interviews are anticipated to take place over a six month period. The study will end when "saturation" is achieved, whereby no new themes are identified through interviews. Saturation will be sought for each individual operation of interest.

Read the detailed description

Safe day-case surgery pathways offer to reduce pressure on hospitals by avoiding overnight inpatient admission. This is particularly relevant given the intense pressures on hospital resources in the United Kingdom. Urological surgery includes a number of frequently performed operations for which safe day-case surgery pathways have been demonstrated. These include bladder tumour resection (TURBT), prostate resection or enucleation using diathermy or laser (TURP and TUEP), and ureteroscopy and laser for upper urinary tract stones (URS). All of these operation types involve endoscopic access to the bladder via the urethra, and do not involve skin incisions. They can be performed under general or spinal anaesthesia, although spinal anaesthesia is rarely used for ureteroscopy.

For the 12 months from December 2021, the national median day-case rate for transurethral resection of bladder tumour In England was 21.1%, and ranged from 0% to 87.3% at different hospitals, with an interquartile range (IQR) of 10.5% to 37.7%, and 23,071 cases performed in total. For bladder outflow obstruction surgery the median day-case rate was 7.7% (range 0% to 82.4%, IQR 4.4% to 19.1%, 18,912 cases), and this includes TURP and TUEP. For URS the median day case rate was 60.1% (range 0% to 87.9%, IQR 44.4% to 69.7%, 23,130 cases). This demonstrates that for these common operations there is significant variation in practice across England.

The Getting It Right First Time (GIRFT) Urology programme advocates for a "day-case by default" approach to TURBT and URS, and that day-case surgery should ideally be offered for prostate resection and enucleation. As well as reducing pressure on inpatient services, greater day-case adoption offers to reduce financial costs, shorten waiting lists by allowing greater access to day-case theatres away from the acute hospital, and reduce environmental impact by adopting a less resource-intensive approach. It also offers a more standardised patient experience.

National day-case rates for all of TURBT, TURP/TUEP and URS have increased over the past five years, however the wide variation in practice identifies a need to understand reasons underlying a significant observed divergence in practice. We want to understand why some hospitals have rapidly adopted day-case surgery whereas others have not. Furthermore, it is necessary to understand any positive and negative outcomes associated with the increased utilisation of day-case surgery. In order to explore this area we intend to perform qualitative research involving members of staff involved in the delivery of one or more of the operations of interest. We will interview staff from a range of different hospitals with differing day-case performances to further understand enablers and barriers associated with day-case adoption. We would also like to understand staff members' experiences of any wider unexpected outcomes associated with day-case surgery adoption.

Being tested
None - qualitative interviews
Medical subject headings
Urinary Bladder Neoplasms, Urinary Bladder Neck Obstruction, Urolithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • None - qualitative interviewsOther

    These are qualitative interviews and involve no intervention

Study groups in NCT06152666
Study groupRoleWhat they receive
StaffMembers of healthcare teams involved in the delivery of day-case endourology operations.
Receives: Other: None - qualitative interviews

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Staff perspectives on delivering day-case endourology surgery

    Obtained through qualitative interview

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2023
  2. Study start1 Dec 2023 (estimated)
  3. Primary completion1 Apr 2024 (estimated)
  4. Study completion1 Oct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06152666
Sponsor's protocol ID
326803
Status last verified
Nov 2023
First submitted
21 Nov 2023
Last updated
1 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: None. Anonymised quotes will be used in the published study report.

Questions about this trial

What is this clinical trial studying?

An observational study of Bladder Cancer and Bladder Outlet Obstruction, run by Royal Devon and Exeter NHS Foundation Trust 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Dec 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Staff perspectives on delivering day-case endourology surgery (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 1 Dec 2023.

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