Kidney CancerROPANNCT03292549
RObotic PArtial Nephrectomy National Study
An observational study of Kidney Cancer, run by University Hospital, Bordeaux at 15 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Robotic partial surgery
- Type of treatment
- Surgery or procedure
- How many people
- 452 participants
- Where
- 15 sitesFrance
- Study dates
- Apr 2014to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients operated for kidney cancer by this surgical procedure
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
CHU Bordeaux
Bordeaux, 33076
CHU Grenoble
La Tronche, 38700
CHRU Lille
Lille, 59000
CHU Limoges
Limoges, 87000
HCL Lyon
Lyon, 69002
CH Diaconesses
Paris, 75012
CHU La Pitié Salpétrière/ Kremlin Bicêtre
Paris, 75013
CH Saint Joseph
Paris, 75014
Hôpital Européen Georges Pompidou
Paris, 75015
CHU Henri MONDOR
Paris, 94010
CHU Rennes - Centre Eugène Marquis
Rennes, 35000
CHU Strasbourg
Strasbourg, 67000
CH Foch
Suresnes, 92151
CHU Toulouse - Centre Claudius Régaud
Toulouse, 31059
CHU Tours
Tours, 37000
About this study
Official title: 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.
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):
- To describe the surgical techniques and operative development.
- To assess the modalities of haemostasis, during robotic partial nephrectomy.
- To assess peri-operative morbidity in robotic partial nephrectomy and post-operative complications.
- To assess the outcome of renal function after a robotic partial nephrectomy. This study is a national, multicenter, prospective, cohort.
- Conditions
- Kidney Cancer
- Being tested
- Robotic partial surgery
- Keywords
- Urology, Robotic surgery, Haemostasis, Partial Nephrectomy
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic partial surgeryProcedure or surgery
Robotic partial surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients | Robotic partial surgery Receives: Procedure: Robotic partial surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative complications evaluated according to the Clavien criteria
Per and post-operative transfusion rates
Measured: From surgery until 1 year of follow up
Post-operative complications evaluated according to the Clavien criteria
Medical or surgical complication rates
Measured: From surgery until 1 year of follow up
Post-operative complications evaluated according to the Clavien criteria
Clavien's grading
Measured: From surgery until 1 year of follow up
Post-operative complications evaluated according to the Clavien criteria
Urinary fistula rate
Measured: From surgery until 1 year of follow up
Post-operative complications evaluated according to the Clavien criteria
Necessity for nephrectomy or re-exploration
Measured: From surgery until 1 year of follow up
Post-operative complications evaluated according to the Clavien criteria
Length of hospital stay
Measured: From surgery until 1 year of follow up
Secondary outcomes (4)
Renal function after robotic partial nephrectomy measured by biological parameters
Creatininemia
Measured: Follow-up during 12 months
Renal function after robotic partial nephrectomy measured by biological parameters
MDRD GFR
Measured: Follow-up during 12 months
Per-operative modalities of haemostasis procedure
Haemostasis procedure
Measured: At Surgery
Per-operative modalities of haemostatic agent
Haemostatic agent
Measured: At Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study startApr 2014
- Primary completionApr 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe BERNHARD, PHU, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292549
- Sponsor's protocol ID
- CHUBX 2012/30
- Acronym
- ROPAN
- Status last verified
- Jul 2016
- First submitted
- 12 Jul 2016
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37407720
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RObotic PArtial Nephrectomy National Study (RoPaN Study)
- ClinicalTrials.gov ID
- NCT03292549
- Acronym / sponsor ID
- ROPAN / CHUBX 2012/30
- Conditions
- Kidney Cancer
- Keywords
- Urology, Robotic surgery, Haemostasis, Partial Nephrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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):
- To describe the surgical techniques and operative development.
- To assess the modalities of haemostasis, during robotic partial nephrectomy.
- To assess peri-operative morbidity in robotic partial nephrectomy and post-operative complications.
- To assess the outcome of renal function after a robotic partial nephrectomy. This study is a national, multicenter, prospective, cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Procedure: Robotic partial surgeryRobotic partial surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated for kidney cancer by this surgical procedure
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic partial surgeryRobotic partial surgery | Procedure or surgery | Patients |
Primary outcome
Post-operative complications evaluated according to the Clavien criteria
Time frame: From surgery until 1 year of follow up
Per and post-operative transfusion rates
Post-operative complications evaluated according to the Clavien criteria
Time frame: From surgery until 1 year of follow up
Medical or surgical complication rates
Post-operative complications evaluated according to the Clavien criteria
Time frame: From surgery until 1 year of follow up
Clavien's grading
Post-operative complications evaluated according to the Clavien criteria
Time frame: From surgery until 1 year of follow up
Urinary fistula rate
Post-operative complications evaluated according to the Clavien criteria
Time frame: From surgery until 1 year of follow up
Necessity for nephrectomy or re-exploration
Post-operative complications evaluated according to the Clavien criteria
Time frame: From surgery until 1 year of follow up
Length of hospital stay
4 secondary outcomes
Renal function after robotic partial nephrectomy measured by biological parameters
Time frame: Follow-up during 12 months
Renal function after robotic partial nephrectomy measured by biological parameters
Time frame: Follow-up during 12 months
Per-operative modalities of haemostasis procedure
Time frame: At Surgery
Per-operative modalities of haemostatic agent
Time frame: At Surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Derived from this study: PubMed 37407720Margue 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Christophe BERNHARD, PHU principal investigator
University Hospital, Bordeaux
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Cancer, run by University Hospital, Bordeaux at 15 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative complications evaluated according to the Clavien criteria (time frame: From surgery until 1 year of follow up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03292549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.