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The purpose of this study is to determine if using robotic surgical technology during bladder cancer surgery helps to reduce complications during and after the surgery. The removal of the bladder and lymph nodes will be done by a robotic or by an open technique. It may be a Robotic-assisted Radical Cystectomy (RARC) and Pelvic Lymph Node Dissection. Or it may be an Open Radical Cystectomy (ORC) and Pelvic Lymph Node Dissection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open radical cystectomy | Active Comparator | This is a prospective, randomized study designed to compare two techniques of radical cystectomy with PLND (open and robotic) for bladder cancer. |
|
| robotic-assisted radical cystectomy | Active Comparator | This is a prospective, randomized study designed to compare two techniques of radical cystectomy with PLND (open and robotic) for bladder cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| open radical cystectomy | Procedure | Open radical cystectomy, pelvic lymph node dissection and open urinary diversion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare surgical complications of robotic-assisted radical cystectomy and open radical cystectomy. | intraoperative and 90-day postoperative period |
| Measure | Description | Time Frame |
|---|---|---|
| To examine clinical and pathological outcomes of robotic-assisted radical cystectomy and open radical cystectomy. | 2 years | |
| Intra-operative performance (surgical time, blood loss) | time from anesthesia induction to final skin closure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Laudone, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25496767 | Derived | Bochner BH, Dalbagni G, Sjoberg DD, Silberstein J, Keren Paz GE, Donat SM, Coleman JA, Mathew S, Vickers A, Schnorr GC, Feuerstein MA, Rapkin B, Parra RO, Herr HW, Laudone VP. Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: A Randomized Clinical Trial. Eur Urol. 2015 Jun;67(6):1042-1050. doi: 10.1016/j.eururo.2014.11.043. Epub 2014 Dec 8. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| robotic-assisted radical cystectomy | Procedure | Robotic radical cystectomy, pelvic lymph node dissection and open urinary diversion. Robotic radical cystectomy is routinely performed by robotically trained and experienced minimally invasive surgeons. |
|
| Pathologic findings, including the stage specific, soft tissue surgical margin rate and number of lymph nodes removed. | 1.5 years |
| Bladder cancer recurrence (local, upper tract and distant disease) | 2 years |
| complications grade 2-5 | A secondary analysis will be used to determine if the total burden of grade 2-5 complications in the robotic arm is different from the open arm. | 2 years |
| complication grade 3-5 | Determine if there is a difference in either the number of patients with grade 3-5 complication or the total number of grade 3-5 complication in the two arms of the study. | 2 years |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |