Enhanced Recovery After Surgery (ERAS) for Ambulatory TURBT

Study Overview
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Brief Summary
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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.

Official Title
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ERAS for Ambulatory TURBT: Enhancing Bladder Cancer Care (EMBRACE) Randomized Controlled Trial Protocol

Conditions
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Bladder Cancer

Intervention / Treatment
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* Other: ERAS Protocol
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with suspected or known bladder cancer Age >= 18 years Undergoing initial or repeat TURBT Ambulatory TURBT with same day discharge home planned Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>Patients in the usual care arm of the trial will experience the present-day care pathway of ambulatory TURBT at Johns Hopkins Hospital. | Other: Standard of Care<br>* Patients in the usual care arm of the EMBRACE trial will experience the present-day care pathway of ambulatory TURBT at Johns Hopkins Hospital.<br>|
| Experimental: ERAS Protocol<br>The ERAS protocol for ambulatory TURBT has been designed based on patient and provider input, a needs assessment of 150 patients in the hours after TURBT, a review of the literature, and experience with other ambulatory ERAS protocols already implemented at Johns Hopkins Hospital. The ERAS protocol for ambulatory TURBT aims to optimize care delivered in the pre, intra and postoperative settings. | Other: ERAS Protocol<br>* The ERAS protocol for ambulatory TURBT has been designed based on patient and provider input, a needs assessment of 150 patients in the hours after TURBT, a review of the literature, and experience with other ambulatory ERAS protocols already implemented at Johns Hopkins Hospital. The ERAS protocol for ambulatory TURBT aims to optimize care delivered in the pre, intra and postoperative settings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of recovery as assessed by Quality-of-Recovery 15 Scores (QoR-15) | 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. | Measured at enrollment through study completion, an average of 7 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lower urinary tract symptoms as assessed by the Urinary Tract Infection-Symptom and Impairment Questionnaire (UTI-SIQ-8) | The UTI-SIQ-8 is a validated questionnaire of voiding symptom severity and bother, with higher scores representing worse symptoms (8-40). | 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) | Bladder Utility Symptom Scale - a validated 10-question instrument designed specifically for patients with bladder cancer, will be used to measure health-related quality of life (0-100), with higher scores representing higher quality of life. | Measured at enrollment through study completion, an average of 7 days. | 
| Change in Pain as assessed by Visual Analogue Scale | Dysuria, Suprapubic/Bladder, Urethral, Penis or Vulvar Pain Rated from 0 (No pain) to 10 (Unbearable pain) | Measured at enrollment through study completion, an average of 7 days. | 
| Change in patient satisfaction as assessed by patient self-report | Self-reported on a scale of 1 (lowest satisfaction) to 10 (highest satisfaction). | Measured at enrollment through study completion, an average of 7 days. | 
| Change in degree of hematuria as assessed by patient self-report | None, Pink, Red, Red with Clots as self-reported by patients | Measured at enrollment through study completion, an average of 7 days. | 
| Change in incontinence | Change in incontinence will be assessed by the average number of pads used per day | Average daily pad use measured at enrollment Measured at enrollment through study completion, an average of 7 days. | 
| Change in opioid consumption | Change in opioid consumption (Morphine milligram equivalents) obtained from medical record | Measured at enrollment through study completion, an average of 7 days. | 
| Healthcare utilization | Number of unplanned post-procedural ambulatory visits, emergency department visits, phone calls, and electronic messages assessed individually. | Measured at enrollment through study completion, an average of 30 days. | 
| Complications as assessed by Clavien-Dindo complications | Surgical complications as classified by Clavien-Dindo category. | Measured at enrollment through study completion, an average of 30 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERAS, Ambulatory Surgery, Quality of Recovery, Quality of Care, Bladder Cancer, Patient-centered outcomes, Enhanced Recovery after Surgery