RObotic PArtial Nephrectomy National Study

Kidney Cancer Clinical Trial

— ROPAN  

Official title:

RObotic PArtial Nephrectomy National Study (RoPaN Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03292549
• Other study ID #: CHUBX 2012/30
• Status: Completed
• Phase: N/A
• First received: July 12, 2016
• Last updated: September 20, 2017
• Start date: April 2014
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 452
• Est. completion date: April 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Procedure:
• Robotic partial surgery
Robotic partial surgery

Locations

Country	Name	City	State
France	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	CH Saint Joseph	Paris
France	CHU Henri MONDOR	Paris
France	CHU La Pitié Salpétrière/ Kremlin Bicêtre	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	CHU Rennes - Centre Eugène Marquis	Rennes
France	CHU Strasbourg	Strasbourg
France	CH Foch	Suresnes
France	CHU Toulouse - Centre Claudius Régaud	Toulouse
France	CHU Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative complications evaluated according to the Clavien criteria	Per and post-operative transfusion rates	From surgery until 1 year of follow up
Primary	Post-operative complications evaluated according to the Clavien criteria	Medical or surgical complication rates	From surgery until 1 year of follow up
Primary	Post-operative complications evaluated according to the Clavien criteria	Clavien's grading	From surgery until 1 year of follow up
Primary	Post-operative complications evaluated according to the Clavien criteria	Urinary fistula rate	From surgery until 1 year of follow up
Primary	Post-operative complications evaluated according to the Clavien criteria	Necessity for nephrectomy or re-exploration	From surgery until 1 year of follow up
Primary	Post-operative complications evaluated according to the Clavien criteria	Length of hospital stay	From surgery until 1 year of follow up
Secondary	Renal function after robotic partial nephrectomy measured by biological parameters	Creatininemia	Follow-up during 12 months
Secondary	Renal function after robotic partial nephrectomy measured by biological parameters	MDRD GFR	Follow-up during 12 months
Secondary	Per-operative modalities of haemostasis procedure	Haemostasis procedure	At Surgery
Secondary	Per-operative modalities of haemostatic agent	Haemostatic agent	At Surgery