Enhanced Recovery After Surgery (ERAS) for Ambulatory TURBT

Sponsor

Johns Hopkins University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05905276

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Jun 1, 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.

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

Outcome Measures

Primary Outcome Measures

Change in quality of recovery as assessed by Quality-of-Recovery 15 Scores (QoR-15) [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

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.]
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) [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 [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 [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 [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 [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 [Measured at enrollment through study completion, an average of 7 days.]
Change in opioid consumption (Morphine milligram equivalents) obtained from medical record
Healthcare utilization [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 [Measured at enrollment through study completion, an average of 30 days.]
Surgical complications as classified by Clavien-Dindo category.