Bladder CancerNCT05905276
Enhanced Recovery After Surgery (ERAS) for Ambulatory TURBT
A study testing ERAS Protocol in people with Bladder Cancer, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- ERAS Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with suspected or known bladder cancer
- Age >= 18 years
- Undergoing initial or repeat TURBT
- Ambulatory TURBT with same day discharge home planned
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ERAS for Ambulatory TURBT: Enhancing Bladder Cancer Care (EMBRACE) Randomized Controlled Trial Protocol
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
- Being tested
- ERAS Protocol, Standard of Care
- Keywords
- ERAS, Ambulatory Surgery, Quality of Recovery, Quality of Care, Bladder Cancer, Patient-centered outcomes, Enhanced Recovery after Surgery
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS ProtocolOther
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 CareOther
Patients in the usual care arm of the EMBRACE trial will experience the present-day care pathway of ambulatory TURBT at Johns Hopkins Hospital.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: ERAS Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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)
The UTI-SIQ-8 is a validated questionnaire of voiding symptom severity and bother, with higher scores representing worse symptoms (8-40).
Measured: 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)
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: Measured at enrollment through study completion, an average of 7 days.
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: Measured at enrollment through study completion, an average of 7 days.
Change in patient satisfaction as assessed by patient self-report
Self-reported on a scale of 1 (lowest satisfaction) to 10 (highest satisfaction).
Measured: Measured at enrollment through study completion, an average of 7 days.
Change in degree of hematuria as assessed by patient self-report
None, Pink, Red, Red with Clots as self-reported by patients
Measured: Measured at enrollment through study completion, an average of 7 days.
Change in incontinence
Change in incontinence will be assessed by the average number of pads used per day
Measured: Average daily pad use measured at enrollment Measured at enrollment through study completion, an average of 7 days.
Change in opioid consumption
Change in opioid consumption (Morphine milligram equivalents) obtained from medical record
Measured: Measured at enrollment through study completion, an average of 7 days.
Healthcare utilization
Number of unplanned post-procedural ambulatory visits, emergency department visits, phone calls, and electronic messages assessed individually.
Measured: Measured at enrollment through study completion, an average of 30 days.
Complications as assessed by Clavien-Dindo complications
Surgical complications as classified by Clavien-Dindo category.
Measured: Measured at enrollment through study completion, an average of 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start3 Dec 2023
- Primary completion30 Jun 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael E Rezaee, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905276
- Sponsor's protocol ID
- IRB00392063
- Status last verified
- Oct 2024
- First submitted
- 6 Jun 2023
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38858157
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERAS for Ambulatory TURBT: Enhancing Bladder Cancer Care (EMBRACE) Randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT05905276
- Acronym / sponsor ID
- IRB00392063
- Conditions
- Bladder Cancer
- Keywords
- ERAS, Ambulatory Surgery, Quality of Recovery, Quality of Care, Bladder Cancer, Patient-centered outcomes, Enhanced Recovery after Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 3 Dec 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of CarePatients in the usual care arm of the trial will experience the present-day care pathway of ambulatory TURBT at Johns Hopkins Hospital. |
| ERAS Protocol | Experimental | Other: ERAS ProtocolThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with suspected or known bladder cancer
- Age >= 18 years
- Undergoing initial or repeat TURBT
- Ambulatory TURBT with same day discharge home planned
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS ProtocolThe 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 |
| Standard of CarePatients in the usual care arm of the EMBRACE trial will experience the present-day care pathway of ambulatory TURBT at Johns Hopkins Hospital. | Other | Standard of Care |
Primary outcome
Change in quality of recovery as assessed by Quality-of-Recovery 15 Scores (QoR-15)
Time frame: 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.
9 secondary outcomes
Change in lower urinary tract symptoms as assessed by the Urinary Tract Infection-Symptom and Impairment Questionnaire (UTI-SIQ-8)
Time frame: 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)
Time frame: Measured at enrollment through study completion, an average of 7 days.
Change in Pain as assessed by Visual Analogue Scale
Time frame: Measured at enrollment through study completion, an average of 7 days.
Change in patient satisfaction as assessed by patient self-report
Time frame: Measured at enrollment through study completion, an average of 7 days.
Change in degree of hematuria as assessed by patient self-report
Time frame: Measured at enrollment through study completion, an average of 7 days.
Change in incontinence
Time frame: Average daily pad use measured at enrollment Measured at enrollment through study completion, an average of 7 days.
Change in opioid consumption
Time frame: Measured at enrollment through study completion, an average of 7 days.
Healthcare utilization
Time frame: Measured at enrollment through study completion, an average of 30 days.
Complications as assessed by Clavien-Dindo complications
Time frame: Measured at enrollment through study completion, an average of 30 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Derived from this study: PubMed 38858157Rezaee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael E Rezaee, MD, MPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS Protocol in people with Bladder Cancer, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of recovery as assessed by Quality-of-Recovery 15 Scores (QoR-15) (time frame: Measured at enrollment through study completion, an average of 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05905276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.