NCT05154084

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19,505

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

2.3 years

First QC Date

October 29, 2021

Last Update Submit

November 12, 2023

Conditions

Bladder Cancer

Keywords

Non muscle-invasive bladder cancerUrothelial carcinomaCollaborative studyQuality improvement

Outcome Measures

Primary Outcomes (4)

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (7)

  • Early recurrence rate

    12 months

  • The rate of achievement of all applicable key TURBT quality indicators

    12 months

  • The rate of Clavien Dindo 3 or more complications

    1 month after surgery

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

    12 months.

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

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Audit only

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

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.

Behavioral: Performance feedback and education

Interventions

Performance feedback and educationBEHAVIORAL

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

Audit with feedback

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Perform TURBT surgery for non-muscle invasive bladder cancer and perform at least 20 first tumour TURBT surgeries per year.
  • ● Patients undergoing transurethral surgical treatment of confirmed transitional cell carcinoma of the bladder

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BURST

London, United Kingdom

Location

Related Publications (1)

  • Gallagher K, Bhatt N, Clement K, Zimmermann E, Khadhouri S, MacLennan S, Kulkarni M, Gaba F, Anbarasan T, Asif A, Light A, Ng A, Chan V, Nathan A, Cooper D, Aucott L, Marcq G, Teoh JY, Hensley P, Duncan E, Goulao B, O'Brien T, Nielsen M, Mariappan P, Kasivisvanathan V. Audit, Feedback, and Education to Improve Quality and Outcomes in Transurethral Resection and Single-Instillation Intravesical Chemotherapy for Nonmuscle Invasive Bladder Cancer Treatment: Protocol for a Multicenter International Observational Study With an Embedded Cluster Randomized Trial. JMIR Res Protoc. 2023 Jun 15;12:e42254. doi: 10.2196/42254.

    PMID: 37318875DERIVED

MeSH Terms

Conditions

Urinary Bladder NeoplasmsNon-Muscle Invasive Bladder NeoplasmsCarcinoma, Transitional Cell

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Veeru Kasivisvanathan, MBBS

    University College, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2021

First Posted

December 10, 2021

Study Start

April 19, 2021

Primary Completion

July 31, 2023

Study Completion

September 30, 2023

Last Updated

November 14, 2023

Record last verified: 2023-11

Locations

GB(1)