Bladder CancerNCT06152679
Day-case Endourology; Patient Experience
An observational study of Bladder Cancer and Bladder Outflow Obstruction, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
A qualitative research study interviewing patients treated in hospitals across England. We will interview patients who have recently undergone one of the following operations as a day-case; transurethral bladder tumour resection (TURBT), transurethral resection of prostate (TURP) or transurethral enucleation of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Bladder Outflow Obstruction
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have recently undergone day-case transurethral resection of bladder tumour (TURBT), transurethral resection of prostate (TURP), or transurethral enucleation of the prostate (TUEP) at an NHS hospital in England.
Who may be able to join
- Adults aged 18 or more
- Experienced day-case TURBT, TURP or TUEP within the past 6 weeks
- Willing and able to provide informed consent
- English speaking
Who cannot join
- Experienced surgery that was not performed as a day-case
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Devon University Healthcare NHS Foundation Trust
Exeter, Devon, EX2 5DW
Joseph B John, BSc, MBBS, +441392411611, joseph.john3@nhs.net
John S McGrath, MBBS, MD, john.mcgrath4@nhs.net
About this study
Official title: Understanding the Patient Experience of Day-case Bladder Tumour Resection, and Prostate Resection or Enucleation: Qualitative Patient Interviews.
A qualitative research study interviewing patients treated in hospitals across England. We will interview patients who have recently undergone one of the following operations as a day-case; transurethral bladder tumour resection (TURBT), transurethral resection of prostate (TURP) or transurethral enucleation of the prostate (TUEP). We are interested to find out about the experience for patients who go home on the day of surgery after they have had one of these operations. We hope that the findings will tell us about how to improve the experience for patients in future.
Patients undergoing day-case surgery at 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 included. 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, but for which day surgery is routine widespread routine practice. These include bladder tumour resection (TURBT), and prostate resection or enucleation using diathermy or laser (TURP and TUEP). 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.
For 12 months from December 2021, the national average 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. 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 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, however we do not understand a great deal about the lived patient experience after discharge.
National day-case rates for of TURBT, and bladder outflow obstruction surgery using TURP or TUEP, have increased over the past five years. Many hospitals have well-established pathways, whilst others are newly adopting this approach, or not yet adopting day-case surgery for these operation types at all. There is an opportunity to understand the patient experience of different day-case surgery pathways for these operations of interest, so that we might understand factors contributing to a favourable or unfavourable experience. This knowledge could inform future day-case pathway development and modification is a way that is more acceptable for patients.
To explore this area, we intend to perform qualitative research involving patients. We will interview patients who were treated at a range of different hospitals with differing day-case performances.
- Conditions
- Bladder Cancer, Bladder Outflow Obstruction
- Being tested
- None - qualitative interviews
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None - qualitative interviewsOther
Qualitative interviews with patients asking about their experience of day-case endourology.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients who have undergone day-case bladder tumour resection or bladder outflow obstruction surgery (prostate resection or enucleation) within the past 6 weeks. Receives: Other: None - qualitative interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient description of their experience
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 posted1 Dec 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Cornwall Hospitals Trust, North Bristol NHS Trust, Gloucestershire Hospitals NHS Foundation Trust, King's College Hospital NHS Trust, Portsmouth Hospitals NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152679
- Sponsor's protocol ID
- 327246
- 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. Only anonymised quotes will be used in published study write-up.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Patient Experience of Day-case Bladder Tumour Resection, and Prostate Resection or Enucleation: Qualitative Patient Interviews.
- ClinicalTrials.gov ID
- NCT06152679
- Acronym / sponsor ID
- 327246
- Conditions
- Bladder Cancer, Bladder Outflow Obstruction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Royal Cornwall Hospitals Trust, North Bristol NHS Trust, Gloucestershire Hospitals NHS Foundation Trust, King's College Hospital NHS Trust, Portsmouth Hospitals NHS Trust
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 1 Dec 2023 (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.
A qualitative research study interviewing patients treated in hospitals across England. We will interview patients who have recently undergone one of the following operations as a day-case; transurethral bladder tumour resection (TURBT), transurethral resection of prostate (TURP) or transurethral enucleation of the prostate (TUEP). We are interested to find out about the experience for patients who go home on the day of surgery after they have had one of these operations. We hope that the findings will tell us about how to improve the experience for patients in future.
Patients undergoing day-case surgery at 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 included. 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.
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, but for which day surgery is routine widespread routine practice. These include bladder tumour resection (TURBT), and prostate resection or enucleation using diathermy or laser (TURP and TUEP). 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.
For 12 months from December 2021, the national average 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. 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 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, however we do not understand a great deal about the lived patient experience after discharge.
National day-case rates for of TURBT, and bladder outflow obstruction surgery using TURP or TUEP, have increased over the past five years. Many hospitals have well-established pathways, whilst others are newly adopting this approach, or not yet adopting day-case surgery for these operation types at all. There is an opportunity to understand the patient experience of different day-case surgery pathways for these operations of interest, so that we might understand factors contributing to a favourable or unfavourable experience. This knowledge could inform future day-case pathway development and modification is a way that is more acceptable for patients.
To explore this area, we intend to perform qualitative research involving patients. We will interview patients who were treated at a range of different hospitals with differing day-case performances.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: None - qualitative interviewsPatients who have undergone day-case bladder tumour resection or bladder outflow obstruction surgery (prostate resection or enucleation) within the past 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have recently undergone day-case transurethral resection of bladder tumour (TURBT), transurethral resection of prostate (TURP), or transurethral enucleation of the prostate (TUEP) at an NHS hospital in England.
Key inclusion criteria (4 listed)
- Adults aged 18 or more
- Experienced day-case TURBT, TURP or TUEP within the past 6 weeks
- Willing and able to provide informed consent
- English speaking
Key exclusion criteria (1 listed)
- Experienced surgery that was not performed as a day-case
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 |
|---|---|---|
| None - qualitative interviewsQualitative interviews with patients asking about their experience of day-case endourology. | Other | Patients |
Primary outcome
Patient description of their experience
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: No. None. Only anonymised quotes will be used in published study write-up.
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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.
Royal Devon University Healthcare NHS Foundation Trust
Exeter, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and Bladder Outflow 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 4 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?
Patient description of their experience (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.