ERAS for Ambulatory TURBT: Enhancing Bladder Cancer Care (EMBRACE) Randomized Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in quality of recovery as assessed by Quality-of-Recovery 15 Scores (QoR-15)
研究概览
简要总结
This is a single-center, randomized-controlled trial to investigate the effectiveness of an ERAS protocol compared to usual care in patients with bladder cancer undergoing ambulatory TURBT. The ERAS protocol is comprised of pre, intra and postoperative components designed to optimize each phase of perioperative care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with suspected or known bladder cancer
- •Age >= 18 years
- •Undergoing initial or repeat TURBT
- •Ambulatory TURBT with same day discharge home planned
排除标准
- •Undergoing a planned concomitant procedure
- •Inability to consent for themselves
- •Unable to complete telephone-based follow up after discharge home
- •Undergoing active treatment for muscle-invasive bladder cancer
结局指标
主要结局
Change in quality of recovery as assessed by Quality-of-Recovery 15 Scores (QoR-15)
时间窗: Measured at enrollment through study completion, an average of 7 days.
The QoR-15 score is a validated 15-item questionnaire that assesses quality of recovery in five dimensions: pain, physical comfort, functional autonomy, emotions, and psychological support. Each item is scored 0 to 10 with higher scores representing superior quality of recovery. The QoR-15 score is patient-reported outcome measure and has been extensively used to evaluate ERAS for both inpatient and ambulatory surgeries. It is a shorter and more patient-friendly version of the QoR-40 with equivalent psychometric properties.
次要结局
- Change in incontinence(Average daily pad use measured at enrollment Measured at enrollment through study completion, an average of 7 days.)
- Complications as assessed by Clavien-Dindo complications(Measured at enrollment through study completion, an average of 30 days.)
- Change in lower urinary tract symptoms as assessed by the Urinary Tract Infection-Symptom and Impairment Questionnaire (UTI-SIQ-8)(Measured at enrollment through study completion, an average of 7 days.)
- Change in quality of life for bladder cancer patients as assessed by the Bladder Utility Symptom Scale (BUSS)(Measured at enrollment through study completion, an average of 7 days.)
- Change in patient satisfaction as assessed by patient self-report(Measured at enrollment through study completion, an average of 7 days.)
- Change in degree of hematuria as assessed by patient self-report(Measured at enrollment through study completion, an average of 7 days.)
- Change in Pain as assessed by Visual Analogue Scale(Measured at enrollment through study completion, an average of 7 days.)
- Change in opioid consumption(Measured at enrollment through study completion, an average of 7 days.)
- Healthcare utilization(Measured at enrollment through study completion, an average of 30 days.)