What side effects are associated with this type of intervention?

Common treatments for bladder cancer, such as radical cystectomy, chemoradiotherapy, and bladder-preserving trimodality therapy, have several known side effects. Radical cystectomy can lead to postoperative ileus, bleeding, and the need for temporary skilled nursing for rehabilitation. Chemoradiotherapy often results in increased rates of grade 3 or 4 toxicity, including gastrointestinal and genitourinary issues. Bladder-preserving trimodality therapy may cause urinary-irritative symptoms, bowel symptoms, and, in some cases, late grade 3 genitourinary or gastrointestinal toxicity. Enhanced Recovery After Surgery (ERAS) protocols aim to mitigate these side effects by optimizing perioperative care, including multimodal pain management and early mobilization.

What prior FDA approvals exist?

The FDA has approved several treatments for bladder cancer that align with multimodal perioperative care pathways like the ERAS protocol. Key approvals include cisplatin-based chemotherapy regimens, which are often used in neoadjuvant settings before radical cystectomy. Immunotherapies such as Atezolizumab and Avelumab have also been approved for advanced or metastatic urothelial carcinoma, providing options for maintenance therapy post-chemotherapy. Additionally, Enfortumab Vedotin has been approved for patients who have previously received platinum-based chemotherapy and PD-1/PD-L1 inhibitors. These treatments aim to improve overall survival and enhance recovery, fitting well within the ERAS framework.

What other types of research exist?

Promising, novel alternatives to the ERAS protocol for bladder cancer patients in 2024 may include: 1) Advanced robotic-assisted surgical techniques, which offer precision and potentially faster recovery times. 2) Personalized medicine approaches, including tailored chemotherapy and immunotherapy regimens based on genetic profiling. 3) Integration of artificial intelligence and machine learning to optimize perioperative care and predict patient outcomes. 4) Enhanced minimally invasive surgical options, such as laparoscopic and endoscopic procedures, which reduce recovery time and complications.

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ERAS Protocol for Bladder Cancer

N/A

Waitlist Available

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

Must not have

Undergoing a planned concomitant procedure

Inability to consent for themselves

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special recovery plan called ERAS for bladder cancer patients having surgery. The plan helps patients get ready for surgery, takes care of them during it, and supports their recovery afterward. Enhanced Recovery After Surgery (ERAS) protocols were introduced to reduce complication rates and hospital stay for patients undergoing major surgeries.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am scheduled for another medical procedure soon.

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I cannot give consent for medical procedures by myself.

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I cannot do follow-up calls after going home.

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I am currently receiving treatment for bladder cancer that has spread into the muscle layer.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for bladder cancer include surgery, chemotherapy, radiation therapy, and chemoradiotherapy. Radical cystectomy involves the surgical removal of the bladder and is often used for muscle-invasive bladder cancer, aiming to eliminate the primary tumor. Chemotherapy uses drugs to kill cancer cells or stop them from growing, and it can be administered before (neoadjuvant) or after (adjuvant) surgery to reduce the risk of recurrence. Radiation therapy uses high-energy rays to target and destroy cancer cells, often used in combination with chemotherapy (chemoradiotherapy) to enhance the effectiveness of treatment. The ERAS protocol, which includes preoperative counseling, medical optimization, and postoperative care, aims to improve recovery times and reduce complications. These treatments are crucial for bladder cancer patients as they offer the potential for curative outcomes, reduce the risk of recurrence, and improve overall survival rates.

Enhanced recovery after surgery review and urology applications in 2020.Current application of the enhanced recovery after surgery protocol for patients undergoing radical cystectomy: lessons learned from European excellence centers.Impact of an enhanced recovery pathway on length of stay and complications in elective radical cystectomy: a before and after cohort study.