RESECT: Improving Quality in TURBT Surgery.

Bladder Cancer Clinical Trial

— RESECT  

Official title:

Transurethral REsection and Single Instillation Intra-vesical Chemotherapy Evaluation in Bladder Cancer Treatment (RESECT) Improving Quality in TURBT Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05154084
• Other study ID #: RESECT Protocol 4.0 111120
• Status: Completed
• Start date: April 19, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2023
• Source: British Urology Researchers in Surgical Training
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19505
• Est. completion date: September 30, 2023
• Est. primary completion date: July 31, 2023
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Behavioral:
• Performance feedback and education
Hospitals and surgeons will have an online interactive performance feedback dashboard provided to them along with educational components.

Locations

Country	Name	City	State
United Kingdom	BURST	London

Sponsors (9)

Lead Sponsor	Collaborator
British Urology Researchers in Surgical Training	Action Bladder Cancer UK, British Journal of Urology International, KARL STORZ Endoscopy-America, Inc., Photocure, Rosetrees Trust, The Urology Foundation, United Kingdom, University College, London, University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of detrusor muscle sampling at TURBT	The proportion of first tumour cases with tumours >5mm in diameter where detrusor muscle is present in the specimen on histological assessment.	At point of surgery, assessed from specimen pathology report.
Primary	The rate of single instillation intra-vesical chemotherapy (SI-IVC) instillation within 24 hours	The proportion of first tumour cases at sites where SI-IVC is possible that were given SI-IVC within 24 hours of TURBT.	24 hours.
Primary	The rate of documentation of resection completeness	The proportion of first tumour cases where a statement of resection completeness is included in the patient operation record.	At time of surgery, assessed retrospectively from patient record.
Primary	The rate of documentation of all of tumour number, tumour size and tumour location in the operative record.	The proportion of first tumour cases where all of tumour number, tumour size and tumour location are documented in the official operative record.	At time of surgery, assessed retrospectively from patient record.
Secondary	Early recurrence rate	The rate of recurrence at first follow up check after complete TURBT.	12 months
Secondary	The rate of achievement of all applicable key TURBT quality indicators	The proportion of first tumour cases achieving all applicable co-primary outcomes. This is a composite outcome that aims to determine if a single metric of quality is associated with cancer recurrence.	12 months
Secondary	The rate of Clavien Dindo 3 or more complications	The rate of Clavien Dindo 3 or more complications	1 month after surgery
Secondary	The association of the achievement of TURBT quality indicators with early recurrence.	A per protocol and per-protocol analysis will be performed to determine if actual achievement of TURBT quality indicators is association with early recurrence rate.	12 months.
Secondary	The association of en-bloc resection or use of visual diagnostic aids with achievement of TURBT quality indicators and early recurrence rate	To determine if the use of en-bloc resection or visual diagnostic aids improves achievement of quality indicators and reduces recurrence	12 months
Secondary	The association of surgeon experience in years and number of TURBTs performed per month with achievement of TURBT quality indicators and early recurrence rate	To determine if surgical experience is important in TURBT quality	12 months
Secondary	The association of dedicated TURBT lists with achievement of TURBT quality indicators and early recurrence rate	To determine if focusing one type of surgery (TURBT) in a dedicated surgical list improves outcomes	12 months