Enhanced Recovery After Surgery (ERAS) for Ambulatory TURBT

NCT05905276 | Completed DMC

• 1 other identifier: IRB00392063
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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 Pain as assessed by Visual Analogue Scale

  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.

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

ERAS Protocol

EXPERIMENTAL

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

Interventions

ERAS Protocol OTHER

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.

ERAS Protocol

Standard of Care OTHER

Patients in the usual care arm of the EMBRACE trial will experience the present-day care pathway of ambulatory TURBT at Johns Hopkins Hospital.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with suspected or known bladder cancer
• Age \>= 18 years
• Undergoing initial or repeat TURBT
• Ambulatory TURBT with same day discharge home planned

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Rezaee ME, Mahon KM, Trock BJ, Nguyen TE, Smith AK, Hahn NM, Patel SH, Kates M. ERAS for Ambulatory TURBT: Enhancing Bladder Cancer Care (EMBRACE) randomised controlled trial protocol. BMJ Open. 2024 Jun 10;14(6):e076763. doi: 10.1136/bmjopen-2023-076763.

  PMID: 38858157 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Michael E Rezaee, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: December 3, 2023
• Primary Completion: June 30, 2024
• Study Completion: October 1, 2024
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)