NCT03292549

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
452

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
Last Updated

September 25, 2017

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

July 12, 2016

Last Update Submit

September 20, 2017

Conditions

Kidney Cancer

Keywords

UrologyRobotic surgeryHaemostasisPartial Nephrectomy

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (4)

  • Renal function after robotic partial nephrectomy measured by biological parameters

    Follow-up during 12 months

  • Renal function after robotic partial nephrectomy measured by biological parameters

    Follow-up during 12 months

  • Per-operative modalities of haemostasis procedure

    At Surgery

  • Per-operative modalities of haemostatic agent

    At Surgery

Study Arms (1)

Patients

Robotic partial surgery

Procedure: Robotic partial surgery

Interventions

Robotic partial surgeryPROCEDURE

Robotic partial surgery

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients operated for kidney cancer by this surgical procedure

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

CHU Bordeaux

Bordeaux, 33076, France

Location

CHU Grenoble

La Tronche, 38700, France

Location

CHRU Lille

Lille, 59000, France

Location

CHU Limoges

Limoges, 87000, France

Location

HCL Lyon

Lyon, 69002, France

Location

CH Diaconesses

Paris, 75012, France

Location

CHU La Pitié Salpétrière/ Kremlin Bicêtre

Paris, 75013, France

Location

CH Saint Joseph

Paris, 75014, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

CHU Henri MONDOR

Paris, 94010, France

Location

CHU Rennes - Centre Eugène Marquis

Rennes, 35000, France

Location

CHU Strasbourg

Strasbourg, 67000, France

Location

CH Foch

Suresnes, 92151, France

Location

CHU Toulouse - Centre Claudius Régaud

Toulouse, 31059, France

Location

CHU Tours

Tours, 37000, France

Location

Related Publications (1)

  • 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.

    PMID: 37407720DERIVED

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Jean-Christophe BERNHARD, PHU

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2016

First Posted

September 25, 2017

Study Start

April 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2016

Last Updated

September 25, 2017

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(15)