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Completed

NCT Number: NCT05154084

RESECT: Improving Quality in TURBT Surgery.

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.

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Key information

Conditions

Bladder Cancer Carcinoma Carcinoma, Transitional Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

BURST

London, United Kingdom

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Performance feedback and education

Behavioral

Hospitals and surgeons will have an online interactive performance feedback dashboard provided to them along with educational components.

Primary outcomes

  1. The rate of detrusor muscle sampling at TURBT

    Time frame: At point of surgery, assessed from specimen pathology report.

    The proportion of first tumour cases with tumours >5mm in diameter where detrusor muscle is present in the specimen on histological assessment.

  2. The rate of single instillation intra-vesical chemotherapy (SI-IVC) instillation within 24 hours

    Time frame: 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.

  3. The rate of documentation of resection completeness

    Time frame: At time of surgery, assessed retrospectively from patient record.

    The proportion of first tumour cases where a statement of resection completeness is included in the patient operation record.

  4. The rate of documentation of all of tumour number, tumour size and tumour location in the operative record.

    Time frame: At time of surgery, assessed retrospectively from patient record.

    The proportion of first tumour cases where all of tumour number, tumour size and tumour location are documented in the official operative record.

Secondary outcomes

  1. Early recurrence rate

    Time frame: 12 months

    The rate of recurrence at first follow up check after complete TURBT.

  2. The rate of achievement of all applicable key TURBT quality indicators

    Time frame: 12 months

    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.

  3. The rate of Clavien Dindo 3 or more complications

    Time frame: 1 month after surgery

    The rate of Clavien Dindo 3 or more complications

  4. The association of the achievement of TURBT quality indicators with early recurrence.

    Time frame: 12 months.

    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.

  5. The association of en-bloc resection or use of visual diagnostic aids with achievement of TURBT quality indicators and early recurrence rate

    Time frame: 12 months

    To determine if the use of en-bloc resection or visual diagnostic aids improves achievement of quality indicators and reduces recurrence

  6. The association of surgeon experience in years and number of TURBTs performed per month with achievement of TURBT quality indicators and early recurrence rate

    Time frame: 12 months

    To determine if surgical experience is important in TURBT quality

  7. The association of dedicated TURBT lists with achievement of TURBT quality indicators and early recurrence rate

    Time frame: 12 months

    To determine if focusing one type of surgery (TURBT) in a dedicated surgical list improves outcomes

Sponsors and collaborators

Lead sponsor

British Urology Researchers in Surgical Training

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: RESECT

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 10, 2021
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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