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Intracorporeal vs Extracorporeal Urinary Diversion for Bladder Cancer

N/A
Recruiting
Led By Mark L Gonzalgo, MD, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical stage T1-T4, N0-1, M0 or refractory carcinoma in situ
Biopsy-proven urothelial cancer being considered for RARC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

Study Summary

This trial suggests that ICD provides superior postoperative outcomes compared to ECD, with less exposure to the external environment, less bowel-related complications, and lower pain scores.

Who is the study for?
This trial is for adults aged 18 to 99 with bladder cancer, who are scheduled for robot-assisted surgery (RARC) and agree to it. They should be in the early or middle stages of cancer (T1-T4, N0-1, M0) or have persistent carcinoma despite treatment. People can't join if they've had major abdominal surgeries that affect robotic surgery safety or conditions like severe lung disease affecting safe anesthesia.Check my eligibility
What is being tested?
The study compares two ways of reconstructing the urinary system after removing the bladder due to cancer using a Da Vinci Robot: one method builds the new passage inside the body (ICD), while another does it outside (ECD). The goal is to see if ICD leads to fewer complications, less pain, and faster recovery.See study design
What are the potential side effects?
Potential side effects may include discomfort at incision sites, bowel-related issues such as constipation or diarrhea due to handling during surgery, infection risks from surgical procedures, and general risks associated with anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is in an early or locally advanced stage, or I have persistent carcinoma in situ.
Select...
My bladder cancer diagnosis was confirmed with a biopsy, and I am being considered for robotic surgery.
Select...
I am scheduled for a robotic-assisted radical cystectomy as agreed with my surgeon.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
90-day Major Post-Operative Complication Rate
Secondary outcome measures
90-day Any Post-Operative Complication Rate
90-day Readmission Rate
Functional Independence Recovery as measured by the ADL Questionnaire
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Intracorporal Urinary Diversion (ICD)Experimental Treatment2 Interventions
Participants will be randomized to receiving ICD after scheduled Robotic Assisted Radical Cystectomy (RARC).
Group II: Extracorporeal Urinary Diversion (ECD)Experimental Treatment1 Intervention
Participants will be randomized to receiving ECD after scheduled Robotic Assisted Radical Cystectomy (RARC).

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
897 Previous Clinical Trials
409,171 Total Patients Enrolled
Mark L Gonzalgo, MD, PhDPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
110 Total Patients Enrolled

Media Library

Extracorporeal Urinary Diversion Clinical Trial Eligibility Overview. Trial Name: NCT03469362 — N/A
Bladder Cancer Research Study Groups: Extracorporeal Urinary Diversion (ECD), Intracorporal Urinary Diversion (ICD)
Bladder Cancer Clinical Trial 2023: Extracorporeal Urinary Diversion Highlights & Side Effects. Trial Name: NCT03469362 — N/A
Extracorporeal Urinary Diversion 2023 Treatment Timeline for Medical Study. Trial Name: NCT03469362 — N/A

Frequently Asked Questions

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

Does this medical research accept elderly individuals in its patient pool?

"As indicated in the eligibility criteria, this study seeks participants aged 18 to 99. Additionally, there are 9 studies that focus on those below the age of majority and 373 for patients above senior citizen status."

Answered by AI

Are doctors currently seeking volunteers for this research?

"Affirmative. The information found on clinicaltrials.gov confirms that this trial is actively recruiting new participants and was first published on April 25th 2018, with the most recent changes being made on February 2nd 2022. A total of 88 individuals are needed from two different medical sites for this project to be completed successfully."

Answered by AI

How many participants have been included in this trial thus far?

"Affirmative. Clinicaltrials.gov contains evidence that this trial, which first went live on April 25th 2018, is currently recruiting individuals for participation. The study requires 88 participants to be sourced from two different sites."

Answered by AI

What demographic is eligible to enroll in this experimentation?

"The trial seeks individuals with bladder cancer, aged 18 to 99 years old. At present, 88 patients have been accepted into the study."

Answered by AI
~4 spots leftby Jun 2024