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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06152679
Other study ID # 327246
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2023
Est. completion date October 1, 2024

Study information

Verified date November 2023
Source Royal Devon and Exeter NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date October 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Experienced surgery that was not performed as a day-case

Study Design


Related Conditions & MeSH terms


Intervention

Other:
None - qualitative interviews
Qualitative interviews with patients asking about their experience of day-case endourology.

Locations

Country Name City State
United Kingdom Royal Devon University Healthcare NHS Foundation Trust Exeter Devon

Sponsors (6)

Lead Sponsor Collaborator
Royal Devon and Exeter NHS Foundation Trust Gloucestershire Hospitals NHS Foundation Trust, King's College Hospital NHS Trust, North Bristol NHS Trust, Portsmouth Hospitals NHS Trust, Royal Cornwall Hospitals Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient description of their experience 6 months
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