Clinical trial NCT03292549: RObotic PArtial Nephrectomy National Study
Official title: RObotic PArtial Nephrectomy National Study (RoPaN Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Cancer
Keywords: Urology
Robotic surgery
Haemostasis
Partial Nephrectomy
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 452
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated for kidney cancer by this surgical procedure

Brief summary: 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: 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):

1. To describe the surgical techniques and operative development.
2. To assess the modalities of haemostasis, during robotic partial nephrectomy.
3. To assess peri-operative morbidity in robotic partial nephrectomy and post-operative complications.
4. To assess the outcome of renal function after a robotic partial nephrectomy. This study is a national, multicenter, prospective, cohort.

Eligibility criteria: 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

Primary outcomes:
measure: Post-operative complications evaluated according to the Clavien criteria
timeFrame: From surgery until 1 year of follow up
measure: Post-operative complications evaluated according to the Clavien criteria
timeFrame: From surgery until 1 year of follow up
measure: Post-operative complications evaluated according to the Clavien criteria
timeFrame: From surgery until 1 year of follow up
measure: Post-operative complications evaluated according to the Clavien criteria
timeFrame: From surgery until 1 year of follow up
measure: Post-operative complications evaluated according to the Clavien criteria
timeFrame: From surgery until 1 year of follow up
measure: Post-operative complications evaluated according to the Clavien criteria
timeFrame: From surgery until 1 year of follow up
Secondary outcomes:
measure: Renal function after robotic partial nephrectomy measured by biological parameters
timeFrame: Follow-up during 12 months
measure: Renal function after robotic partial nephrectomy measured by biological parameters
timeFrame: Follow-up during 12 months
measure: Per-operative modalities of haemostasis procedure
timeFrame: At Surgery
measure: Per-operative modalities of haemostatic agent
timeFrame: At Surgery
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
city: La Tronche
country: France
facility: CHU Grenoble
city: Lille
country: France
facility: CHRU Lille
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: HCL Lyon
city: Paris
country: France
facility: CH Diaconesses
city: Paris
country: France
facility: CHU La Pitié Salpétrière/ Kremlin Bicêtre
city: Paris
country: France
facility: CH Saint Joseph
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: CHU Henri MONDOR
city: Rennes
country: France
facility: CHU Rennes - Centre Eugène Marquis
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Suresnes
country: France
facility: CH Foch
city: Toulouse
country: France
facility: CHU Toulouse - Centre Claudius Régaud
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: University Hospital, Bordeaux
name: Jean-Christophe BERNHARD, PHU
role: PRINCIPAL_INVESTIGATOR
References: