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ERAS Protocol for Bladder Cancer

N/A

Recruiting

Led By Michael E Rezaee, MD, MPH

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ambulatory TURBT with same day discharge home planned

Age >= 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at enrollment through study completion, an average of 30 days.

Awards & highlights

Study Summary

This trial will compare a care plan to improve care for bladder cancer surgery patients to usual care.

Who is the study for?

This trial is for adults over 18 with suspected or known bladder cancer, who are scheduled for an outpatient procedure called TURBT and can go home the same day. It's not for those having additional procedures, unable to consent, cannot do phone follow-ups, or actively treating muscle-invasive bladder cancer.Check my eligibility

What is being tested?

The study compares a special care plan called ERAS (Enhanced Recovery After Surgery) with standard care in patients having TURBT surgery. The ERAS protocol aims to improve recovery by optimizing preoperative preparation, care during and after surgery.See study design

What are the potential side effects?

Since this trial involves comparing different perioperative care protocols rather than medications, side effects may include typical surgical risks such as infection or discomfort related to the procedure itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a same-day bladder tumor surgery and will go home the same day.

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I am 18 years old or older.

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I am scheduled for or have had a bladder tumor surgery.

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I have or might have bladder cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at enrollment through study completion, an average of 30 days.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at enrollment through study completion, an average of 30 days.

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at enrollment through study completion, an average of 30 days. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Change in Pain as assessed by Visual Analogue Scale

Change in degree of hematuria as assessed by patient self-report

Change in incontinence

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ERAS ProtocolExperimental Treatment1 Intervention

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 II: Standard of CareActive Control1 Intervention

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,273 Previous Clinical Trials

14,840,223 Total Patients Enrolled

Michael E Rezaee, MD, MPHPrincipal InvestigatorJohns Hopkins University

Media Library

ERAS Protocol Clinical Trial Eligibility Overview. Trial Name: NCT05905276 — N/A

Bladder Cancer Research Study Groups: Standard of Care, ERAS Protocol

Bladder Cancer Clinical Trial 2023: ERAS Protocol Highlights & Side Effects. Trial Name: NCT05905276 — N/A

ERAS Protocol 2023 Treatment Timeline for Medical Study. Trial Name: NCT05905276 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any vacancies available for individuals to join this clinical trial?

"As indicated on clinicaltrials.gov, this research trial is no longer seeking participants; the last update to its posting was June 14th 2023. Fortunately, there are still 386 other trials actively recruiting patients at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enhanced Recovery After Surgery (ERAS) for Ambulatory TURBT

2023. "Enhanced Recovery After Surgery (ERAS) for Ambulatory TURBT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05905276.