Bladder CancerRESECTNCT05154084
RESECT: Improving Quality in TURBT Surgery.
An observational study of Bladder Cancer, run by British Urology Researchers in Surgical Training at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Performance feedback and education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 19,505 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Apr 2021to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
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.
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 locations and contacts
1 site in 1 country.
About this study
Official title: Transurethral REsection and Single Instillation Intra-vesical Chemotherapy Evaluation in Bladder Cancer Treatment (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.
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- Performance feedback and education
- Keywords
- Non muscle-invasive bladder cancer, Urothelial carcinoma, Collaborative study, Quality improvement
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performance feedback and educationBehavioural
Hospitals and surgeons will have an online interactive performance feedback dashboard provided to them along with educational components.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Performance feedback and education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At time of surgery, assessed retrospectively from patient record.
Secondary outcomes (7)
Early recurrence rate
The rate of recurrence at first follow up check after complete TURBT.
Measured: 12 months
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.
Measured: 12 months
The rate of Clavien Dindo 3 or more complications
The rate of Clavien Dindo 3 or more complications
Measured: 1 month after surgery
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.
Measured: 12 months.
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
Measured: 12 months
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
Measured: 12 months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start19 Apr 2021
- Primary completion31 Jul 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 19,505 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Urology Researchers in Surgical Training
- Sponsor type
- University, hospital or other
- Collaborators
- Action Bladder Cancer UK, British Journal of Urology International, Rosetrees Trust, Photocure, KARL STORZ Endoscopy-America, Inc., University College, London, University of Aberdeen, The Urology Foundation, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Veeru Kasivisvanathan, MBBS, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154084
- Sponsor's protocol ID
- RESECT Protocol 4.0 111120
- Acronym
- RESECT
- Status last verified
- Nov 2023
- First submitted
- 29 Oct 2021
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Country specific data to be provided to regional lead on request and with conditions.
Publications
Orecchia L, Gerardi M, Colalillo G, Leonardis F, Rosato E, Asimakopoulos AD, Gallagher KM, Bhatt N, Khadhouri S, Kasivisvanathan V, Finazzi Agro E, Miano R, Albisinni S. Impact of audit and feedback on transurethral resection of bladder tumour quality: a monocentric post-completion evaluation of the RESECT trial. BJU Int. 2026 Jul;138(1):92-99. doi: 10.1111/bju.70266. Epub 2026 Apr 1.
PubMed 41919786Gallagher 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.
PubMed 37318875
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transurethral REsection and Single Instillation Intra-vesical Chemotherapy Evaluation in Bladder Cancer Treatment (RESECT) Improving Quality in TURBT Surgery
- ClinicalTrials.gov ID
- NCT05154084
- Acronym / sponsor ID
- RESECT / RESECT Protocol 4.0 111120
- Conditions
- Bladder Cancer
- Keywords
- Non muscle-invasive bladder cancer, Urothelial carcinoma, Collaborative study, Quality improvement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19,505 participants (actual)
- Lead sponsor
- British Urology Researchers in Surgical TrainingUniversity, hospital or other
- Collaborators
- Action Bladder Cancer UK, British Journal of Urology International, Rosetrees Trust, Photocure, KARL STORZ Endoscopy-America, Inc., University College, London, University of Aberdeen, The Urology Foundation, United Kingdom
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Behavioral: Performance feedback and educationThis 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Performance feedback and educationHospitals and surgeons will have an online interactive performance feedback dashboard provided to them along with educational components. | Behavioural | Audit with feedback |
Primary outcome
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.
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.
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.
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.
7 secondary outcomes
Early recurrence rate
Time frame: 12 months
The rate of achievement of all applicable key TURBT quality indicators
Time frame: 12 months
The rate of Clavien Dindo 3 or more complications
Time frame: 1 month after surgery
The association of the achievement of TURBT quality indicators with early recurrence.
Time frame: 12 months.
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
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
The association of dedicated TURBT lists with achievement of TURBT quality indicators and early recurrence rate
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Derived from this study: PubMed 41919786Orecchia L, Gerardi M, Colalillo G, Leonardis F, Rosato E, Asimakopoulos AD, Gallagher KM, Bhatt N, Khadhouri S, Kasivisvanathan V, Finazzi Agro E, Miano R, Albisinni S. Impact of audit and feedback on transurethral resection of bladder tumour quality: a monocentric post-completion evaluation of the RESECT trial. BJU Int. 2026 Jul;138(1):92-99. doi: 10.1111/bju.70266. Epub 2026 Apr 1.
- Derived from this study: PubMed 37318875Gallagher 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.
- Individual participant dataSharing planned: Undecided. Country specific data to be provided to regional lead on request and with conditions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veeru Kasivisvanathan, MBBS principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by British Urology Researchers in Surgical Training at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of detrusor muscle sampling at TURBT (time frame: At point of surgery, assessed from specimen pathology report.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05154084, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.