Clinical and Economic Outcomes of Radical Cystectomy Among NMIBC and MIBC Patients: Nationwide Claims-Based Study in Korea
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1
- 主要终点
- Cohort B: Number of Participants Reporting Post-Operative Complications Within 12 Months After Radical Cystectomy (RC)
研究概览
简要总结
The purpose of this study is to assess participant's overall well-being and the extent to which medical services are used by participants with non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC) who have undergone radical cystectomy (surgical procedure to remove entire urinary bladder). NMIBC is a type of bladder cancer in which cancer is confined to innermost lining of the bladder and MIBC is a type of bladder cancer in which cancer has grown deep into the thick muscle of the bladder.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants newly diagnosed with bladder cancer (BC) (International statistical classification of diseases and related health problems, 10th revision [ICD-10] codes of malignant neoplasm of the bladder [C67] or carcinoma in-situ of bladder [D090] and cancer-specific insurance code of Korean national health insurance service [V193]) between September 1 2015 and August 31 2023
- •Having two outpatients or one inpatient visit anytime in the study period for BC
排除标准
- •Participants with a history of BC diagnosis or cystectomy during the pre-index period
- •Participants with prior primary malignancy (ICD-10 codes) that was under active treatment or follow-up during the pre-index period
- •Participants with evidence of metastatic disease at the index date, defined as: a. Having secondary malignancy codes (ICD-10 codes), or b. Having received systemic chemotherapy for BC within 6 months of the initial transurethral resection of the bladder tumor (TURBT)
研究组 & 干预措施
Cohort A: NMIBC/MIBC Cohort
Participants newly diagnosed with non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC) between September 1, 2015, and August 31, 2017 will be enrolled in Cohort A. Data will be collected using the health insurance review & assessment (HIRA) claim database. No drug will be given as a part of the study.
Cohort B: RC cohort
Participants from a subset of Cohort A, who have undergone radical cystectomy (RC) will be enrolled into Cohort B. Data will be collected using the HIRA claim database. No drug will be given as a part of the study.
结局指标
主要结局
Cohort B: Number of Participants Reporting Post-Operative Complications Within 12 Months After Radical Cystectomy (RC)
时间窗: Up to 12 months post RC procedure
Number of participants in Cohort B reporting post-operative complications (including hemorrhage/bleeding, cardiac, respiratory, gastrointestinal, genitourinary, wound and hernia, thrombosis/embolic, infection and sepsis, renal failure, metabolic disturbances, dehydration, failure to thrive, malnutrition, neurologic, psychiatric conditions, and miscellaneous and surgical) within 12 months after RC (overall and by disease stage) will be reported.
Cohort B: Number of Participants Reporting Post-Operative Complications Within 3 Years After RC
时间窗: Up to 3 years post RC procedure
Number of participants in Cohort B reporting post-operative complications (including hemorrhage/bleeding, cardiac, respiratory, gastrointestinal, genitourinary, wound and hernia, thrombosis/embolic, infection and sepsis, renal failure, metabolic disturbances, dehydration, failure to thrive, malnutrition, neurologic, psychiatric conditions, and miscellaneous and surgical) within 3 years after RC (overall and by disease stage) will be reported.
Cohort B: Mortality Within 30 days After RC
时间窗: Up to 30 days post RC procedure
Number of deaths (mortality) amongst participants in Cohort B post-RC procedure will be reported.
Cohort B: Mortality Within 90 days After RC
时间窗: Up to 90 days post RC procedure
Number of deaths (mortality) amongst participants in Cohort B post-RC procedure will be reported.
Cohort B: Length Of Stay (LOS) for Hospitalization for RC
时间窗: Up to 3 years post RC procedure
LOS for the hospitalization for RC in participants from Cohort B will be reported.
Cohort B: Number of Participants with Readmission Within 30 Days After RC
时间窗: Up to 30 days post RC procedure
Number of participants from Cohort B with readmission after RC will be reported.
Cohort B: Number of Participants with Readmission Within 90 Days After RC
时间窗: Up to 90 days post RC procedure
Number of participants from Cohort B with readmission after RC will be reported.
Cohort B: Number of Participants with Readmission Within 12-Months After RC
时间窗: Up to 12-month post RC procedure
Number of participants from Cohort B with readmission after RC will be reported.
Cohort B: Number of Hospital Visits Within 12-Months After RC
时间窗: Up to 12 months post RC procedure
Number of hospital visits (outpatient, inpatient, and emergency) of participants from Cohort B within 12 months after RC will be reported.
Cohort B: Number of Hospital Visits Within 3 Years After RC
时间窗: Up to 3 years post RC procedure
Number of hospital visits (outpatient, inpatient, and emergency) of participants from Cohort B within 3 years after RC will be reported.
次要结局
- Cohort A: Percentage of Participants by Bladder Cancer Stage(At Baseline)
- Cohort A: Treatment Patterns: Type of Treatment(Up to approximately 5 years)
- Cohort A: Treatment Pattern: Number of Participants Receiving Intravesical Chemotherapy(Up to approximately 5 years)
- Cohort A: BCG Treatment Status: Percentage of Participants Receiving the BCG Induction and Maintenance Therapy(Up to approximately 5 years)
- Cohort A: BCG Treatment Status: Number of BCG Maintenance Cycles(Up to approximately 5 years)
- Cohort A: BCG Treatment Status: Total Duration of BCG Therapy(Up to approximately 5 years)
- Cohort B: Time from Diagnosis to RC(Up to approximately 8 years)
- Cohort B: Time from Last BCG to RC(Up to approximately 8 years)
- Cohort B: Occurrence of Any Postoperative Complications Within the 12 Months post-RC Procedure(Up to 12 months post RC procedure)
- Cohort B: Total Costs from Diagnosis to RC(Up to approximately 8 years)
- Cohort B: Total Costs for the Period after RC(Up to 30 days, 90 days, 12 months and 3 years post-RC procedure)
- Cohort B: Total Cost for Hospitalization for RC(Up to approximately 8 years)