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To date, no trials have been designed to compare open Vs laparoscopic radical cystectomy in the elderly patients, both in terms of functional and clinical outcome measures. A more meaningful comparison of the two modalities is that of a randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic radical cystectomy | Experimental | Surgery: Laparoscopic radical cystectomy with open urinary diversion |
|
| Open radical cystectomy | Active Comparator | Surgery: Open radical cystectomy with open urinary diversion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic radical cystectomy with open urinary diversion | Procedure | Laparoscopic surgical procedure in which the bladder is removed because of bladder cancer and a urinary diversion is performed |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate | Comparison of the complication rate among the two cohorts of patients under investigation according to the Clavien classification. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life | Comparison of health related quality of life among the two cohorts under investigation according to the SF-36 questionnaire | 24 months |
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Inclusion Criteria:
4.Recent (within 6 weeks of cystectomy) total body CT imaging study excluding distant metastases as well as upper urinary tract TCC
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincenzo VP Pagliarulo, M.D. | Contact | +39 080 5595228 | vpagliarulo@urologia.uniba.it |
| Name | Affiliation | Role |
|---|---|---|
| Vincenzo VP Pagliarulo, M.D. | Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vincenzo Pagliarulo | Recruiting | Bari | Italy | 70124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18403100 | Background | Haber GP, Crouzet S, Gill IS. Laparoscopic and robotic assisted radical cystectomy for bladder cancer: a critical analysis. Eur Urol. 2008 Jul;54(1):54-62. doi: 10.1016/j.eururo.2008.03.076. Epub 2008 Apr 1. | |
| 19116095 | Background | Hemal AK. Robotic and laparoscopic radical cystectomy in the management of bladder cancer. Curr Urol Rep. 2009 Jan;10(1):45-54. doi: 10.1007/s11934-009-0009-8. |
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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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| Open radical cystectomy with open urinary diversion | Procedure | Open surgical procedure in which the bladder is removed because of bladder cancer and a urinary diversion is performed |
|
| 12173348 | Background | Edwards BK, Howe HL, Ries LA, Thun MJ, Rosenberg HM, Yancik R, Wingo PA, Jemal A, Feigal EG. Annual report to the nation on the status of cancer, 1973-1999, featuring implications of age and aging on U.S. cancer burden. Cancer. 2002 May 15;94(10):2766-92. doi: 10.1002/cncr.10593. |
| 18410437 | Background | Chamie K, Hu B, Devere White RW, Ellison LM. Cystectomy in the elderly: does the survival benefit in younger patients translate to the octogenarians? BJU Int. 2008 Aug;102(3):284-90. doi: 10.1111/j.1464-410X.2008.07636.x. Epub 2008 Apr 11. |
| 17113703 | Background | Nielsen ME, Shariat SF, Karakiewicz PI, Lotan Y, Rogers CG, Amiel GE, Bastian PJ, Vazina A, Gupta A, Lerner SP, Sagalowsky AI, Schoenberg MP, Palapattu GS; Bladder Cancer Research Consortium (BCRC). Advanced age is associated with poorer bladder cancer-specific survival in patients treated with radical cystectomy. Eur Urol. 2007 Mar;51(3):699-706; discussion 706-8. doi: 10.1016/j.eururo.2006.11.004. Epub 2006 Nov 13. |
| 3558716 | Background | Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8. |
| 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 |