search
Back to results

Enhanced Recovery After Surgery (ERAS) for Ambulatory TURBT

Primary Purpose

Bladder Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ERAS Protocol
Standard of Care
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring ERAS, Ambulatory Surgery, Quality of Recovery, Quality of Care, Bladder Cancer, Patient-centered outcomes, Enhanced Recovery after Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

ERAS Protocol

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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)
Change in patient satisfaction as assessed by patient self-report
Self-reported on a scale of 1 (lowest satisfaction) to 10 (highest satisfaction).
Change in degree of hematuria as assessed by patient self-report
None, Pink, Red, Red with Clots as self-reported by patients
Change in incontinence
Change in incontinence will be assessed by the average number of pads used per day
Change in opioid consumption
Change in opioid consumption (Morphine milligram equivalents) obtained from medical record
Healthcare utilization
Number of unplanned post-procedural ambulatory visits, emergency department visits, phone calls, and electronic messages assessed individually.
Complications as assessed by Clavien-Dindo complications
Surgical complications as classified by Clavien-Dindo category.

Full Information

First Posted
June 6, 2023
Last Updated
September 8, 2023
Sponsor
Johns Hopkins University
search

1. Study Identification

Unique Protocol Identification Number
NCT05905276
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
ERAS, Ambulatory Surgery, Quality of Recovery, Quality of Care, Bladder Cancer, Patient-centered outcomes, Enhanced Recovery after Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Patients in the usual care arm of the trial will experience the present-day care pathway of ambulatory TURBT at Johns Hopkins Hospital.
Arm Title
ERAS Protocol
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
ERAS Protocol
Intervention Description
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 Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Patients in the usual care arm of the EMBRACE trial will experience the present-day care pathway of ambulatory TURBT at Johns Hopkins Hospital.
Primary Outcome Measure Information:
Title
Change in quality of recovery as assessed by Quality-of-Recovery 15 Scores (QoR-15)
Description
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.
Time Frame
Measured at enrollment through study completion, an average of 7 days.
Secondary Outcome Measure Information:
Title
Change in lower urinary tract symptoms as assessed by the Urinary Tract Infection-Symptom and Impairment Questionnaire (UTI-SIQ-8)
Description
The UTI-SIQ-8 is a validated questionnaire of voiding symptom severity and bother, with higher scores representing worse symptoms (8-40).
Time Frame
Measured at enrollment through study completion, an average of 7 days.
Title
Change in quality of life for bladder cancer patients as assessed by the Bladder Utility Symptom Scale (BUSS)
Description
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.
Time Frame
Measured at enrollment through study completion, an average of 7 days.
Title
Change in Pain as assessed by Visual Analogue Scale
Description
Dysuria, Suprapubic/Bladder, Urethral, Penis or Vulvar Pain Rated from 0 (No pain) to 10 (Unbearable pain)
Time Frame
Measured at enrollment through study completion, an average of 7 days.
Title
Change in patient satisfaction as assessed by patient self-report
Description
Self-reported on a scale of 1 (lowest satisfaction) to 10 (highest satisfaction).
Time Frame
Measured at enrollment through study completion, an average of 7 days.
Title
Change in degree of hematuria as assessed by patient self-report
Description
None, Pink, Red, Red with Clots as self-reported by patients
Time Frame
Measured at enrollment through study completion, an average of 7 days.
Title
Change in incontinence
Description
Change in incontinence will be assessed by the average number of pads used per day
Time Frame
Average daily pad use measured at enrollment Measured at enrollment through study completion, an average of 7 days.
Title
Change in opioid consumption
Description
Change in opioid consumption (Morphine milligram equivalents) obtained from medical record
Time Frame
Measured at enrollment through study completion, an average of 7 days.
Title
Healthcare utilization
Description
Number of unplanned post-procedural ambulatory visits, emergency department visits, phone calls, and electronic messages assessed individually.
Time Frame
Measured at enrollment through study completion, an average of 30 days.
Title
Complications as assessed by Clavien-Dindo complications
Description
Surgical complications as classified by Clavien-Dindo category.
Time Frame
Measured at enrollment through study completion, an average of 30 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael E Rezaee, MD, MPH
Phone
4109554494
Email
mrezaee2@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rana Harb
Email
rharb1@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael E Rezaee, MD, MPH
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael E Rezaee, MD, MPH
Phone
410-955-4494
Email
mrezaee2@jhmi.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Enhanced Recovery After Surgery (ERAS) for Ambulatory TURBT

We'll reach out to this number within 24 hrs