Enhanced Recovery After Surgery (ERAS) for Ambulatory TURBT

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05905276
• Other study ID #: IRB00392063
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 3, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: June 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 1, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.