Bladder CancerNCT03469362
Intracorporeal vs Extracorporeal Urinary Diversion After Robot Assisted Radical Cystectomy
A study testing Extracorporeal Urinary Diversion and Intracorporal Urinary Diversion in people with Bladder Cancer, run by University of Miami at 1 site in United States.
Trial summary
Intracorporeal urinary diversion (ICD) provides superior postoperative outcomes compared to extracorporeal urinary diversion (ECD). The investigators' hypothesis that ICD may provide clinical benefit is based on principles of less bowel and ureteral handling, superior operating room workflow, less exposure to the… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Extracorporeal Urinary Diversion and Intracorporal Urinary Diversion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2018to 11 Sep 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven urothelial cancer being considered for RARC.
- Clinical stage T1-T4, N0-1, M0 or refractory carcinoma in situ.
- Subject must be already scheduled to have a RARC at the discretion of the surgeon and with the patient's agreement.
Who cannot join
- Inability to give informed consent
- Prior major abdominal and pelvic open surgical procedures that would preclude a safe robotic approach, as determined by the treating surgeon.
- At the discretion of the treating surgeon, any pre-existing condition such as severe chronic obstructive pulmonary disease that precludes a safe initiation or maintenance of pneumoperitoneum over a prolonged period of time and during surgery.
- Age <18 or >99 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial of Intracorporeal vs Extracorporeal Urinary Diversion After Robot Assisted Radical Cystectomy
Intracorporeal urinary diversion (ICD) provides superior postoperative outcomes compared to extracorporeal urinary diversion (ECD). The investigators' hypothesis that ICD may provide clinical benefit is based on principles of less bowel and ureteral handling, superior operating room workflow, less exposure to the external environment, and optimal visualization with ICD while utilizing a smaller incision compared to ECD. ICD should have less bowel-related complications, lower pain scores allowing patients to be discharged from the hospital sooner and regain functional independence more quickly.
- Conditions
- Bladder Cancer
- Being tested
- Extracorporeal Urinary Diversion, Intracorporal Urinary Diversion
- 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.
Extracorporeal Urinary DiversionProcedure or surgery
Also called ECD
Extra-corporeal urinary diversion, provided as part of standard of care, will have the ureters sutured into the ileal conduit by hand.
Intracorporal Urinary DiversionProcedure or surgery
Also called ICD
Intracorporal Urinary Diversion, provided as part of standard of care, will have the ureters sutured into the ileal conduit using the Da Vinci robot.
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal Urinary Diversion (ECD) | Experimental | Participants will be randomized to receiving ECD after scheduled Robotic Assisted Radical Cystectomy (RARC). Receives: Procedure: Extracorporeal Urinary Diversion |
| Intracorporal Urinary Diversion (ICD) | Experimental | Participants will be randomized to receiving ICD after scheduled Robotic Assisted Radical Cystectomy (RARC). Receives: Procedure: Intracorporal Urinary Diversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day Major Post-Operative Complication Rate
Major complication rate at 90-days from RARC + urinary diversion using the modified Clavien-Dindo grading system. Major complication is defined as Clavien-Dindo Grade ≥ 3.
Measured: 90 days
Secondary outcomes (12)
90-day Any Post-Operative Complication Rate
Any complication rates at 90-days from RARC + urinary diversion, using the modified Clavien-Dindo grading system as low grade (1-2) or high grade (3-5).
Measured: 90 days
Length of Hospital Stay in ECD vs ICD Study Participants
Length of hospital stay for study participants undergoing ECD versus ICD urinary diversion post-RARC, as recorded at hospital discharge.
Measured: About 2 weeks
90-day Readmission Rate
Rate of readmission to hospital at 90 days post-RARC followed by ECD or ICD urinary diversion.
Measured: 90 days
Rate of Return to the Operating room within 90 days
Rate of return to the operating room within 90 days after RARC followed by ICD or ECD Urinary Diversion.
Measured: Up to 90 days
Mortality Rate at 90 days
Rate of mortality (death) at 90 days in study participants
Measured: 90 days
Rate of Bowel-Specific Complications
Rate of bowel-specific complications in study participants (including incidence of mechanical bowel obstruction, anastomotic leaks, and surgical site infections) and post operative pain. Bowel-specific complications will be assessed using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Measured: Up to 36 months
Functional Independence Recovery as measured by the ADL Questionnaire
Rate of functional independence recovery as measured by patient-reported scores on the Activities of Daily Living (ADL) questionnaire. For the ADL, the total score ranges from 0 to 6, with the higher scores indicating functional improvement and lower scores indicating functional deterioration.
Measured: Up to 36 months
Functional Independence Recovery as measured by the IADL Questionnaire
Rate of functional independence recovery as measured by an aggregate of patient-reported scores on the Instrumental Activities of Daily Living (IADL) questionnaire. For the IADL, the total score ranges from 0 to 8, with higher scores indicating functional functional improvement and lower scores indicating functional deterioration.
Measured: Up to 36 months
Functional Independence Recovery as measured by the Hand Grip Strength Test.
The Hand Grip Strength Test measures the amount of static force that a participant's hand can squeeze around a dynamometer. The test is measured in kilograms.
Measured: Up to 36 months
Functional Independence Recovery as measured by the Timed Up and Go (TUG) Walking Test
The TUG test times participants as they rise from a standard chair, walk 3 meters, turn, walk back and sit again. The test is measured in seconds.
Measured: Up to 36 months
Health-Related Quality of Life (HRQoL) as assessed by SF-8 Health Survey
HRQoL measured by patient scores on the Short Form 8 (SF-8) Health Survey. The SF-8 is a questionnaire consisting of 8-items and two component summary scores: Physical component summary (PCS) and mental component summary (MCS). They are scored by weighting each score to a norm-based scoring model. The total scores will be reported as a percentile with higher score indicating better health-related quality of life.
Measured: Up to 36 months
HRQoL as assessed by the FACT-VCI Questionnaire
HRQoL measured by patient scores on the Functional Assessment of Cancer Therapy-Vanderbilt Cystectomy Index (FACT-VCI) questionnaire. The FACT-VCI is a condition-specific instrument for patients undergoing radical cystectomy (RC) and urinary diversion (UD) for bladder cancer. The questionnaire consists of 44 items scored on a range from 0 ("Not at all") to 4 ("Very Much"), resulting in an ordinal Likert scale, with higher scores indicating a better HRQoL. The FACT-VCI measures quality of life across five domains: Physical wellbeing, social/family wellbeing, emotional wellbeing, functional wellbeing and an additional concerns subscale.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start25 Apr 2018
- Primary completion20 Aug 2024
- Study completion11 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark L. Gonzalgo, MD, PhD, University of Miami
- Investigators
- Mark L Gonzalgo, MD, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469362
- Sponsor's protocol ID
- 20170004
- Status last verified
- Nov 2024
- First submitted
- 6 Mar 2018
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Intracorporeal vs Extracorporeal Urinary Diversion After Robot Assisted Radical Cystectomy
- ClinicalTrials.gov ID
- NCT03469362
- Acronym / sponsor ID
- 20170004
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 19 Mar 2018 (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.
Intracorporeal urinary diversion (ICD) provides superior postoperative outcomes compared to extracorporeal urinary diversion (ECD). The investigators' hypothesis that ICD may provide clinical benefit is based on principles of less bowel and ureteral handling, superior operating room workflow, less exposure to the external environment, and optimal visualization with ICD while utilizing a smaller incision compared to ECD. ICD should have less bowel-related complications, lower pain scores allowing patients to be discharged from the hospital sooner and regain functional independence more quickly.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal Urinary Diversion (ECD) | Experimental | Procedure: Extracorporeal Urinary DiversionParticipants will be randomized to receiving ECD after scheduled Robotic Assisted Radical Cystectomy (RARC). |
| Intracorporal Urinary Diversion (ICD) | Experimental | Procedure: Intracorporal Urinary DiversionParticipants will be randomized to receiving ICD after scheduled Robotic Assisted Radical Cystectomy (RARC). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Biopsy-proven urothelial cancer being considered for RARC.
- Clinical stage T1-T4, N0-1, M0 or refractory carcinoma in situ.
- Subject must be already scheduled to have a RARC at the discretion of the surgeon and with the patient's agreement.
Key exclusion criteria (4 listed)
- Inability to give informed consent
- Prior major abdominal and pelvic open surgical procedures that would preclude a safe robotic approach, as determined by the treating surgeon.
- At the discretion of the treating surgeon, any pre-existing condition such as severe chronic obstructive pulmonary disease that precludes a safe initiation or maintenance of pneumoperitoneum over a prolonged period of time and during surgery.
- Age <18 or >99 years.
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 |
|---|---|---|
| Extracorporeal Urinary DiversionAlso: ECDExtra-corporeal urinary diversion, provided as part of standard of care, will have the ureters sutured into the ileal conduit by hand. | Procedure or surgery | Extracorporeal Urinary Diversion (ECD) |
| Intracorporal Urinary DiversionAlso: ICDIntracorporal Urinary Diversion, provided as part of standard of care, will have the ureters sutured into the ileal conduit using the Da Vinci robot. | Procedure or surgery | Intracorporal Urinary Diversion (ICD) |
Primary outcome
90-day Major Post-Operative Complication Rate
Time frame: 90 days
Major complication rate at 90-days from RARC + urinary diversion using the modified Clavien-Dindo grading system. Major complication is defined as Clavien-Dindo Grade ≥ 3.
12 secondary outcomes
90-day Any Post-Operative Complication Rate
Time frame: 90 days
Length of Hospital Stay in ECD vs ICD Study Participants
Time frame: About 2 weeks
90-day Readmission Rate
Time frame: 90 days
Rate of Return to the Operating room within 90 days
Time frame: Up to 90 days
Mortality Rate at 90 days
Time frame: 90 days
Rate of Bowel-Specific Complications
Time frame: Up to 36 months
Functional Independence Recovery as measured by the ADL Questionnaire
Time frame: Up to 36 months
Functional Independence Recovery as measured by the IADL Questionnaire
Time frame: Up to 36 months
Functional Independence Recovery as measured by the Hand Grip Strength Test.
Time frame: Up to 36 months
Functional Independence Recovery as measured by the Timed Up and Go (TUG) Walking Test
Time frame: Up to 36 months
Health-Related Quality of Life (HRQoL) as assessed by SF-8 Health Survey
Time frame: Up to 36 months
HRQoL as assessed by the FACT-VCI Questionnaire
Time frame: Up to 36 months
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 25 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
Mark L Gonzalgo, MD, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Urinary Diversion and Intracorporal Urinary Diversion in people with Bladder Cancer, run by University of Miami 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 3 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 25 Mar 2025. 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?
90-day Major Post-Operative Complication Rate (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2025.