Enhanced Recovery After Surgery (ERAS) for Ambulatory TURBT

NCT ID: NCT05905276

Last Updated: 2024-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-03

Study Completion Date

2024-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

ERAS Protocol

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael E Rezaee, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38858157 (View on PubMed)

Other Identifiers

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IRB00392063

Identifier Type: -

Identifier Source: org_study_id

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