About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥ 18 years
RPLND of residual mass after chemotherapy in patient with testicular neoplasm seminomatous or nonseminomatous performed by open, laparoscopic, or robotic technique
Primary RPLND for seminomatous or nonseminomatous testicular neoplasm of stage I or IIA-IIB with negative markers performed with open, laparoscopic or robotic technique
RPLND performed by open, laparoscopic, or robotic technique for the treatment of tumors seminomatous or nonseminomatous chemiorefractory testicular tumors progressing after I and II line of chemotherapy
Disqualifiers
Patient with comorbidities with contraindication to surgery
Hemorrhagic diathesis
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Overall Survival (OS) and Recurrence-Free Survival (RFS)
To evaluate oncological outcomes, namely Overall Survival (OS) and Recurrence-Free Survival (RFS), of O-RPLND
Secondary outcomes
Intraoperative and postoperative complications
To describe intraoperative and postoperative complications, including ejaculatory disorders.
Sponsors and contacts
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