RObotic PArtial Nephrectomy National Study

Completed

• Conditions: Kidney Cancer
• Interventions: Procedure: Robotic partial surgery

• Registration Number: NCT03292549
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2015-04
• Study Completion: 2016-04
• Status Verified: 2016-07
• Study First Submitted: 2016-07-12
• Study First Submitted QC: 2017-09-20
• Last Update Submitted: 2017-09-20
• Study First Posted: 2017-09-25
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 452

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Robotic partial surgery	Robotic partial surgery

Primary Outcome Measures

Name	Time	Method
Post-operative complications evaluated according to the Clavien criteria	From surgery until 1 year of follow up	Length of hospital stay

Secondary Outcome Measures

Name	Time	Method
Per-operative modalities of haemostatic agent	At Surgery	Haemostatic agent
Renal function after robotic partial nephrectomy measured by biological parameters	Follow-up during 12 months	MDRD GFR
Per-operative modalities of haemostasis procedure	At Surgery	Haemostasis procedure

Trial Locations

Locations (15)

CHU Bordeaux; 🇫🇷 Bordeaux, France

CHU Grenoble; 🇫🇷 La Tronche, France

CHRU Lille; 🇫🇷 Lille, France

CHU Limoges; 🇫🇷 Limoges, France

HCL Lyon; 🇫🇷 Lyon, France

CH Diaconesses; 🇫🇷 Paris, France

CHU La Pitié Salpétrière/ Kremlin Bicêtre; 🇫🇷 Paris, France

CH Saint Joseph; 🇫🇷 Paris, France

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

CHU Henri MONDOR; 🇫🇷 Paris, France

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