Clinical trial NCT05905276: Enhanced Recovery After Surgery (ERAS) for Ambulatory TURBT
Official title: ERAS for Ambulatory TURBT: Enhancing Bladder Cancer Care (EMBRACE) Randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: ERAS
Ambulatory Surgery
Quality of Recovery
Quality of Care
Bladder Cancer
Patient-centered outcomes
Enhanced Recovery after Surgery
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in quality of recovery as assessed by Quality-of-Recovery 15 Scores (QoR-15)
timeFrame: Measured at enrollment through study completion, an average of 7 days.
Secondary outcomes:
measure: Change in lower urinary tract symptoms as assessed by the Urinary Tract Infection-Symptom and Impairment Questionnaire (UTI-SIQ-8)
timeFrame: Measured at enrollment through study completion, an average of 7 days.
measure: Change in quality of life for bladder cancer patients as assessed by the Bladder Utility Symptom Scale (BUSS)
timeFrame: Measured at enrollment through study completion, an average of 7 days.
measure: Change in Pain as assessed by Visual Analogue Scale
timeFrame: Measured at enrollment through study completion, an average of 7 days.
measure: Change in patient satisfaction as assessed by patient self-report
timeFrame: Measured at enrollment through study completion, an average of 7 days.
measure: Change in degree of hematuria as assessed by patient self-report
timeFrame: Measured at enrollment through study completion, an average of 7 days.
measure: Change in incontinence
timeFrame: Average daily pad use measured at enrollment Measured at enrollment through study completion, an average of 7 days.
measure: Change in opioid consumption
timeFrame: Measured at enrollment through study completion, an average of 7 days.
measure: Healthcare utilization
timeFrame: Measured at enrollment through study completion, an average of 30 days.
measure: Complications as assessed by Clavien-Dindo complications
timeFrame: Measured at enrollment through study completion, an average of 30 days.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Michael E Rezaee, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: