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

Tracking Information

• First Submitted Date: June 6, 2023
• First Posted Date: June 15, 2023
• Last Update Posted Date: December 13, 2023
• Actual Study Start Date: December 3, 2023
• Estimated Primary Completion Date: May 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 14, 2023)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 14, 2023)

• 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).
• 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.
• 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)
• 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).
• 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
• 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
• 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
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Enhanced Recovery After Surgery (ERAS) for Ambulatory TURBT
• Official Title: ERAS for Ambulatory TURBT: Enhancing Bladder Cancer Care (EMBRACE) Randomized Controlled Trial Protocol
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Bladder Cancer

Intervention

• 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.
• 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.

Study Arms

• 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.
  Intervention: Other: Standard of Care
• 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.
  Intervention: Other: ERAS Protocol

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 14, 2023): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2024
• Estimated Primary Completion Date: May 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

Contact: Rana Harb; rharb1@jhmi.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05905276
• Other Study ID Numbers: IRB00392063
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Johns Hopkins University
• Original Responsible Party: Same as current
• Current Study Sponsor: Johns Hopkins University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Johns Hopkins University
• Verification Date: December 2023