Transurethral REsection and Single Instillation Intra-vesical Chemotherapy Evaluation in Bladder Cancer Treatment (RESECT) Improving Quality in TURBT Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19,505
- 试验地点
- 1
- 主要终点
- The rate of detrusor muscle sampling at TURBT
研究概览
简要总结
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.
详细描述
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?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The rate of detrusor muscle sampling at TURBT
时间窗: 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
时间窗: 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
时间窗: 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.
时间窗: 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.
次要结局
- 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)
- The association of surgeon experience in years and number of TURBTs performed per month with achievement of TURBT quality indicators and early recurrence rate(12 months)
- The association of dedicated TURBT lists with achievement of TURBT quality indicators and early recurrence rate(12 months)