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The aim of this study is to evaluate the oncologic and functional outcomes of RPLND as primary treatment (stage I and IIA-IIB with negative markers) or of residual masses after chemotherapy (PC-RPLND) in the treatment of patients with seminomatous and non-seminomatous.
In order to evaluate the role and the͛clinical impact of different surgical techniques of RPLND will be included patients treated with open, laparoscopic, and robot-assisted techniques
The purpose of this study is to evaluate the oncologic and functional outcomes of RPLND as primary treatment or residual masses after chemotherapy in the treatment of patients with seminomatous and nonseminomatous tumors.
In order to evaluate the role and clinical impact of different surgical techniques of RPLND will be included patients treated with open, laparoscopic, and robot-assisted techniques.
The study will be divided into two phases (a prospective and a retrospective phase):
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) and Recurrence-Free Survival (RFS) | To evaluate oncological outcomes, namely Overall Survival (OS) and Recurrence-Free Survival (RFS), of O-RPLND | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative and postoperative complications | To describe intraoperative and postoperative complications, including ejaculatory disorders. | up to 3 months |
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Inclusion Criteria:
Exclusion criteria:
RETROSPECTIVE PHASE. Patients with the same inclusion and exclusion criteria as in the prospective phase and already undergoing RPLND surgery with open, laparoscopic, or robotic technique from January 2000 to December 2020 in the͛framework of the normal course of care with a minimum follow-up of 12 months. (estimated to include approximately 120 patients).
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Phase 1 prospective Patients selected for the prospective phase will undergo open, laparoscopic, or robotic according to the usual care pathway; follow-up visits will follow the normal clinic practice.
Retrospective phase 2 Patients selected for the retrospective phase underwent open, laparoscopic, or robotic according to the normal course of care from January 2000 to December 2020 and have already been undergone follow-up postoperative examinations and examinations according to normal clinical practice with follow-up up of 5 years.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angelo Mottaran, MD | Contact | +39 3398946529 | angelo.mottaran2@unibo.it |
| Name | Affiliation | Role |
|---|---|---|
| Eugenio Brunocilla, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Recruiting | Bologna | Bologna | 40138 | Italy |
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| ID | Term |
|---|---|
| D013736 | Testicular Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005834 | Genital Neoplasms, Male |
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| UO di Chirurgia Urologica della Fondazione IRCCS Istituto Nazionale dei Tumori di Milano | Recruiting | Milan | Italy | Italy |
|
| D014565 |
| Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |