Enhanced Recovery After Surgery (ERAS) for Ambulatory TURBT

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

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.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Other: Standard of Care; Other: ERAS Protocol

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; 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; Patients in the usual care arm of the EMBRACE trial will experience the present-day care pathway of ambulatory TURBT at Johns Hopkins Hospital.
Experimental: ERAS Protocol; 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; 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Michael E Rezaee, MD, MPH, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2023
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Bladder Cancer; Quality of Recovery; ERAS; Quality of Care; Patient-centered outcomes; Enhanced Recovery after Surgery; Ambulatory Surgery
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: IRB00392063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No