RObotic PArtial Nephrectomy National Study

NCT ID: NCT03292549

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

452 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-04-30

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):

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.

Conditions

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Kidney Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Robotic partial surgery

Robotic partial surgery

Intervention Type PROCEDURE

Robotic partial surgery

Interventions

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Robotic partial surgery

Robotic partial surgery

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Christophe BERNHARD, PHU

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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CHU Bordeaux

Bordeaux, , France

Site Status

CHU Grenoble

La Tronche, , France

Site Status

CHRU Lille

Lille, , France

Site Status

CHU Limoges

Limoges, , France

Site Status

HCL Lyon

Lyon, , France

Site Status

CH Diaconesses

Paris, , France

Site Status

CHU La Pitié Salpétrière/ Kremlin Bicêtre

Paris, , France

Site Status

CH Saint Joseph

Paris, , France

Site Status

Hôpital Européen Georges Pompidou

Paris, , France

Site Status

CHU Henri MONDOR

Paris, , France

Site Status

CHU Rennes - Centre Eugène Marquis

Rennes, , France

Site Status

CHU Strasbourg

Strasbourg, , France

Site Status

CH Foch

Suresnes, , France

Site Status

CHU Toulouse - Centre Claudius Régaud

Toulouse, , France

Site Status

CHU Tours

Tours, , France

Site Status

Countries

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France

References

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Margue G, Ingels A, Bensalah K, Doumerc N, Vaessen C, Roupret M, Audenet F, Mejean A, Bruyere F, Olivier J, Baumert H, Michel C, Paparel P, Parier B, Sebe P, Long JA, Lang H, Lebret T, Patard JJ, Bernhard JC. Late complications and 5 years outcomes of robotic partial nephrectomy in France: prospective assessment in the French Kidney Cancer Research Network (UroCCR 10). World J Urol. 2023 Aug;41(8):2281-2288. doi: 10.1007/s00345-023-04491-z. Epub 2023 Jul 6.

Reference Type DERIVED
PMID: 37407720 (View on PubMed)

Other Identifiers

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CHUBX 2012/30

Identifier Type: -

Identifier Source: org_study_id