RObotic PArtial Nephrectomy National Study

Study Overview
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Brief Summary
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The purpose of the study is to set up the larger prospective study on robotic partial nephrectomy, to describe the characteristics of patients operated for kidney cancer by this surgical procedure and also to determine the modalities of hemostasis in this procedure.

Detailed Description
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The primary objective of the study is to describe the characteristics of patients operated for kidney cancer by a robotic partial nephrectomy in France (recruiting centers, patient profile, tumor characteristics). Secondary Objective(s): To describe the surgical techniques and operative development. To assess the modalities of haemostasis, during robotic partial nephrectomy. To assess peri-operative morbidity in robotic partial nephrectomy and post-operative complications. To assess the outcome of renal function after a robotic partial nephrectomy. This study is a national, multicenter, prospective, cohort.

Official Title
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RObotic PArtial Nephrectomy National Study (RoPaN Study)

Conditions
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Kidney Cancer

Intervention / Treatment
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* Procedure: Robotic partial surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is at least 18 years old at the time of screening Subject has been diagnosed with renal tumor(s) Subject will undergo a robot assisted partial nephrectomy Subject is willing and able to comply with the requirements of the protocol Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Robotic partial surgery | Procedure: Robotic partial surgery<br>* Robotic partial surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative complications evaluated according to the Clavien criteria | Per and post-operative transfusion rates | From surgery until 1 year of follow up | 
| Post-operative complications evaluated according to the Clavien criteria | Medical or surgical complication rates | From surgery until 1 year of follow up | 
| Post-operative complications evaluated according to the Clavien criteria | Clavien's grading | From surgery until 1 year of follow up | 
| Post-operative complications evaluated according to the Clavien criteria | Urinary fistula rate | From surgery until 1 year of follow up | 
| Post-operative complications evaluated according to the Clavien criteria | Necessity for nephrectomy or re-exploration | From surgery until 1 year of follow up | 
| Post-operative complications evaluated according to the Clavien criteria | Length of hospital stay | From surgery until 1 year of follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function after robotic partial nephrectomy measured by biological parameters | Creatininemia | Follow-up during 12 months | 
| Renal function after robotic partial nephrectomy measured by biological parameters | MDRD GFR | Follow-up during 12 months | 
| Per-operative modalities of haemostasis procedure | Haemostasis procedure | At Surgery | 
| Per-operative modalities of haemostatic agent | Haemostatic agent | At Surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urology, Robotic surgery, Haemostasis, Partial Nephrectomy