CClinicalTrials.gg
CompletedNCT03292549ROPANUpdated Sep 25, 2017

RObotic PArtial Nephrectomy National Study

An observational study in Kidney Cancer, sponsored by University Hospital, Bordeaux. Completed at 15 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-25.

Sponsored by University Hospital, Bordeaux · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
452
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Kidney Cancer

Browse trials for

Keywords

  • Urology
  • Robotic surgery
  • Haemostasis
  • Partial Nephrectomy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients operated for kidney cancer by this surgical procedure

Eligibility criteria

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

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
452 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients

    Robotic partial surgery

    Procedure: Robotic partial surgery

Interventions

  • ProcedureRobotic partial surgery

    Robotic partial surgery

05

What researchers measure

Primary outcomes

  1. Post-operative complications evaluated according to the Clavien criteria

    Per and post-operative transfusion rates

    Time frame: From surgery until 1 year of follow up

  2. Post-operative complications evaluated according to the Clavien criteria

    Medical or surgical complication rates

    Time frame: From surgery until 1 year of follow up

  3. Post-operative complications evaluated according to the Clavien criteria

    Clavien's grading

    Time frame: From surgery until 1 year of follow up

  4. Post-operative complications evaluated according to the Clavien criteria

    Urinary fistula rate

    Time frame: From surgery until 1 year of follow up

  5. Post-operative complications evaluated according to the Clavien criteria

    Necessity for nephrectomy or re-exploration

    Time frame: From surgery until 1 year of follow up

  6. Post-operative complications evaluated according to the Clavien criteria

    Length of hospital stay

    Time frame: From surgery until 1 year of follow up

Secondary outcomes

  1. Renal function after robotic partial nephrectomy measured by biological parameters

    Creatininemia

    Time frame: Follow-up during 12 months

  2. Renal function after robotic partial nephrectomy measured by biological parameters

    MDRD GFR

    Time frame: Follow-up during 12 months

  3. Per-operative modalities of haemostasis procedure

    Haemostasis procedure

    Time frame: At Surgery

  4. Per-operative modalities of haemostatic agent

    Haemostatic agent

    Time frame: At Surgery

06

Study locations

15 sites
  • CHU Bordeaux
    Bordeaux, 33076, France
  • CHU Grenoble
    La Tronche, 38700, France
  • CHRU Lille
    Lille, 59000, France
  • CHU Limoges
    Limoges, 87000, France
  • HCL Lyon
    Lyon, 69002, France
  • CH Diaconesses
    Paris, 75012, France
  • CHU La Pitié Salpétrière/ Kremlin Bicêtre
    Paris, 75013, France
  • CH Saint Joseph
    Paris, 75014, France
  • Hôpital Européen Georges Pompidou
    Paris, 75015, France
  • CHU Henri MONDOR
    Paris, 94010, France
  • CHU Rennes - Centre Eugène Marquis
    Rennes, 35000, France
  • CHU Strasbourg
    Strasbourg, 67000, France
  • CH Foch
    Suresnes, 92151, France
  • CHU Toulouse - Centre Claudius Régaud
    Toulouse, 31059, France
  • CHU Tours
    Tours, 37000, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03292549
Lead sponsor
University Hospital, Bordeaux
Responsible party
Sponsor
First posted
Sep 25, 2017
Start date
Apr 2014
Primary completion
Apr 2015
Completion
Apr 2016
Last update
Sep 25, 2017

Study contacts

Jean-Christophe BERNHARD, PHU
principal investigator · University Hospital, Bordeaux

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion