RESECT: Improving Quality in TURBT Surgery.

British Urology Researchers in Surgical Training

Status: Completed

Conditions: Bladder Cancer

Treatments: Behavioral: Performance feedback and education

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05154084

RESECT Protocol 4.0 111120

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19,505 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

19,505 participants in 2 patient groups

Audit only

Description:

This group of sites will participate in the audit. No performance feedback will be provided during the period under study. Feedback will be provided at the end of the study period.

Audit with feedback

Description:

This group of sites will participate in the audit, and receive a feedback intervention about their practice based on retrospective data about surgery performed before the start of the study period.

Treatment:

Behavioral: Performance feedback and education