Enhanced Recovery After Surgery (ERAS) for Ambulatory TURBT

• ClinicalTrials.gov Identifier: NCT05905276
• Recruitment Status: Recruiting
• First Posted: June 15, 2023
• Last Update Posted: December 13, 2023
• Sponsor: Johns Hopkins University
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Bladder Cancer	Other: ERAS Protocol; Other: Standard of Care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ERAS for Ambulatory TURBT: Enhancing Bladder Cancer Care (EMBRACE) Randomized Controlled Trial Protocol
• Actual Study Start Date: December 3, 2023
• Estimated Primary Completion Date: May 2024
• Estimated Study Completion Date: June 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in quality of recovery as assessed by Quality-of-Recovery 15 Scores (QoR-15) [ Time Frame: 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.

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Michael E Rezaee, MD, MPH; 4109554494; mrezaee2@jhmi.edu

Contact: Rana Harb; rharb1@jhmi.edu

Locations

United States, Maryland

Johns Hopkins Hospital; Recruiting

Baltimore, Maryland, United States, 21287

Contact: Michael E Rezaee, MD, MPH 410-955-4494 mrezaee2@jhmi.edu

Sponsors and Collaborators

Johns Hopkins University

Investigators

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

More Information

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT05905276
• Other Study ID Numbers: IRB00392063
• First Posted: June 15, 2023
• Last Update Posted: December 13, 2023
• Last Verified: December 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:

ERAS; Ambulatory Surgery; Quality of Recovery; Quality of Care; Bladder Cancer; Patient-centered outcomes; Enhanced Recovery after Surgery

Additional relevant MeSH terms:

Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases