Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06152666 |
| Other study ID # |
326803 |
| 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 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.
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.
