Clinical trial NCT05154084: RESECT: Improving Quality in TURBT Surgery.
Official title: Transurethral REsection and Single Instillation Intra-vesical Chemotherapy Evaluation in Bladder Cancer Treatment (RESECT) Improving Quality in TURBT Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Keywords: Non muscle-invasive bladder cancer
Urothelial carcinoma
Collaborative study
Quality improvement
Lead sponsor: British Urology Researchers in Surgical Training
Sponsor class: OTHER
Collaborators: name: Action Bladder Cancer UK
name: British Journal of Urology International
name: Rosetrees Trust
name: Photocure
name: KARL STORZ Endoscopy-America, Inc.
name: University College, London
name: University of Aberdeen
name: The Urology Foundation, United Kingdom
First posted: 2021-12-10
Enrollment: 19505
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Site: Primary analysis and randomization is at the site level. Patients are not randomized and audit performance outcomes are analysed at the site level. Estimated 200 sites total sample.

Patient: Patients undergoing TURBT for a first or recurrent transitional cell carcinoma presumed to be non-muscle invasive at the time of surgery.

Brief summary: Superficial bladder cancer, known as non-muscle-invasive bladder cancer (NMIBC), is the most common type of bladder cancer. It is expensive to manage and significantly impacts on patients' quality of life. This is because there is a high burden of recurrent disease after initial treatment, and need for long term surveillance for recurrence.

The most important step in the diagnosis and treatment of NMIBC is the first surgical procedure called the transurethral resection of bladder tumour (TURBT). There is evidence that the quality of the TURBT operation, and the use of a single administration of bladder chemotherapy following the operation, can reduce cancer recurrence rates and progression to more invasive cancer. There is anecdotal evidence that the quality of TURBT surgery and the usage of intravesical chemotherapy varies widely between hospitals and thus may result in worse outcomes for some patients.

The primary objective of the study is to determine if audit and feedback can improve the quality of TURBT surgery and if this reduces recurrence of NMIBC.

Detailed description: RESECT aims to be the largest multicentre international observational study evaluating the first and most important step in the management of non muscle-invasive bladder cancer (NMIBC), the transurethral resection of bladder tumour (TURBT).

It is known that achieving a "good quality" TURBT results in reduced NMIBC recurrence rates. This evidence forms the basis for the recommendations made in evidence-based guidelines such as the European Association of Urology (EAU), the American Urological Association (AUA) and the National Institute for Health and Care Excellence (NICE). The RESECT study will evaluate the effects of a variety of patient, hospital, surgical and surgeon-related factors which may contribute to altered outcome in patients with NMIBC following a TURBT.

The only known national data collection about quality standards in TURBT surgery is in Scotland. The aim is to conduct a multicentre international observational study of urological practice for the management of NMIBC. Current operative practice will be measured across hospitals, regions and countries and compare these against evidence-based recommendations. It will be determined if any hospital, service, training or technical factors impact the achievement of quality indicators and/or early recurrence rates. These data will be used to present hospital and surgeon performance back to surgeons as an intervention to drive quality improvement. The timing of feedback to different hospitals will be varied randomly so that it can determined if the feedback is having an impact on audit performance.

RESECT aims to answer some key UNKNOWNS:

Does reporting and comparing our TURBT quality make us do it better? What things should be measured to determine TURBT quality? What rate of achievement should be aimed for in our practice? What factors are associated with better achievement of TURBT quality?

Methods:

The is an observational study that will include randomized feedback and education to hospitals about their TURBT performance.

Sites will first submit survey data about usual practice, and then retrospective data about consecutive TURBT surgery previously performed at their site.

Sites will then be randomized to either receiving early feedback or to not receiving early feedback and just taking part in the study. Sites will then collect prospective data about consecutive TURBT surgeries performed at their site.

Performance will then be compared between hospitals that received feedback during the study and those who did not. All sites will receive the feedback intervention at the end of the study.

Eligibility criteria: Site inclusion criteria:

Perform TURBT surgery for non-muscle invasive bladder cancer and perform at least 20 first tumour TURBT surgeries per year.

Case Inclusion criteria:

● Patients undergoing transurethral surgical treatment of confirmed transitional cell carcinoma of the bladder

Case Exclusion criteria

* Radiologically suspected muscle invasive bladder cancer pre-operatively
* Surgery not performed with curative intent: a. Diagnostic purposes only b. Symptomatic or palliative purposes only c. diffuse lesions that cannot cured by TURBT surgery
* Emergency TURBT
* Records lacking pre-defined minimum data set
* All records from sites where the study minimum requirements are not met

Primary outcomes:
measure: The rate of detrusor muscle sampling at TURBT
timeFrame: At point of surgery, assessed from specimen pathology report.
measure: The rate of single instillation intra-vesical chemotherapy (SI-IVC) instillation within 24 hours
timeFrame: 24 hours.
measure: The rate of documentation of resection completeness
timeFrame: At time of surgery, assessed retrospectively from patient record.
measure: The rate of documentation of all of tumour number, tumour size and tumour location in the operative record.
timeFrame: At time of surgery, assessed retrospectively from patient record.
Secondary outcomes:
measure: Early recurrence rate
timeFrame: 12 months
measure: The rate of achievement of all applicable key TURBT quality indicators
timeFrame: 12 months
measure: The rate of Clavien Dindo 3 or more complications
timeFrame: 1 month after surgery
measure: The association of the achievement of TURBT quality indicators with early recurrence.
timeFrame: 12 months.
measure: The association of en-bloc resection or use of visual diagnostic aids with achievement of TURBT quality indicators and early recurrence rate
timeFrame: 12 months
measure: The association of surgeon experience in years and number of TURBTs performed per month with achievement of TURBT quality indicators and early recurrence rate
timeFrame: 12 months
measure: The association of dedicated TURBT lists with achievement of TURBT quality indicators and early recurrence rate
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: BURST
Study officials:
affiliation: University College, London
name: Veeru Kasivisvanathan, MBBS
role: PRINCIPAL_INVESTIGATOR
References: