RObotic PArtial Nephrectomy National Study (ROPAN)

RObotic PArtial Nephrectomy National Study (RoPaN Study)

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.

Study Overview

• Status: Completed
• Conditions: Kidney Cancer
• Intervention / Treatment: Procedure: Robotic partial surgery

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 Type: Observational
• Enrollment (Actual): 452

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • CHU Bordeaux
  • La Tronche, France, 38700
    • CHU Grenoble
  • Lille, France, 59000
    • CHRU LILLE
  • Limoges, France, 87000
    • CHU Limoges
  • Lyon, France, 69002
    • HCL Lyon
  • Paris, France, 75015
    • Hôpital Européen Georges Pompidou
  • Paris, France, 75012
    • CH Diaconesses
  • Paris, France, 75013
    • CHU La Pitié Salpétrière/ Kremlin Bicêtre
  • Paris, France, 75014
    • Ch Saint Joseph
  • Paris, France, 94010
    • CHU Henri Mondor
  • Rennes, France, 35000
    • CHU Rennes - Centre Eugène Marquis
  • Strasbourg, France, 67000
    • CHU Strasbourg
  • Suresnes, France, 92151
    • CH Foch
  • Toulouse, France, 31059
    • CHU Toulouse - Centre Claudius Régaud
  • Tours, France, 37000
    • CHU Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients operated for kidney cancer by this surgical procedure

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Robotic partial surgery	Procedure: Robotic partial surgery; Robotic partial surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Jean-Christophe BERNHARD, PHU, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: July 12, 2016
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): September 25, 2017
• Last Update Submitted That Met QC Criteria: September 20, 2017
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Robotic surgery; Partial Nephrectomy; Urology; Haemostasis
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Kidney Neoplasms
• Other Study ID Numbers: CHUBX 2012/30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No