Renal CancerNCT05168761
Complications Associated With Partial Nephrectomy for Renal Cancer
An observational study of Renal Cancer and Partial Nephrectomy, run by Central Hospital, Nancy, France.
Trial summary
This paper evaluates the initial complications and the complications two years postoperatively necessitating re-hospitalisation for three surgical procedures for renal tumour partial nephrectomy . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Cancer, Partial Nephrectomy
- What is being tested?
- partial nephrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 7,664 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: In total, there were 11,698 hospitalisations between the 1st January 2016 and the 31st December 2017 with one of the PN codes from the Classification Commune des Actes Médicaux (CCAM) (Annex 1). The investigators used a supplementary filter for the diagnosis of renal cancer, C64, from the International Classification of Diseases 10th edition (ICD-10). The Department of Medical Informatics, Nancy CHRU controlled coding discrepancies, leaving 9119 hospitalisations for study
Who may be able to join
- hospitalisations between the 1st January 2016 and the 31st December 2017 with one of the partial nephrectomy codes
Who cannot join
- partial nephrectomy for non-cancerous pathology
- no technical information
About this study
Official title: Complications Associated With Partial Nephrectomy for Renal Cancer: PMSI French National Data
This paper evaluates the initial complications and the complications two years postoperatively necessitating re-hospitalisation for three surgical procedures for renal tumour partial nephrectomy .
Read the detailed description
This paper evaluates the initial complications and the complications two years postoperatively necessitating re-hospitalisation for three surgical procedures for renal tumour partial nephrectomy (open (OPN), standard laparoscopy (LPN) and robot assisted laparoscopy (RAPN)) in 2016-2017 in France (9119 initial hospitalisations included 4035 OPN, 1900 RAPN, 1709 LPN). The investigators have extracted for these all hospitalisations from the French national hospital data base (PMSI-MCO). The investigators concluded mini-invasive and robotic surgery had lower morbidity and a shorter initial hospitalisation.
- Conditions
- Renal Cancer, Partial Nephrectomy
- Being tested
- partial nephrectomy
- Keywords
- nephron sparing, robot, PMSI, laparoscopy, open surgery, nephron sparing surgery
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
partial nephrectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic partial nephrectomy | The investigators included all hospitalisations for LPN using CCAM(Classification Commune des actes médicaux) code (JAFC005) after removing the 83 hospitals using RAPN in 2017. LPN complications were from hospitals using exclusively LPN. Receives: Procedure: partial nephrectomy | |
| open partial nephrectomy | OPN has its own CCAM codes; they group laparotomy (JAFA019 / JAFA030) and lumbotomy (JAFA008 / JAFA024) Receives: Procedure: partial nephrectomy | |
| robot assisted partial nephrectomy | At the time of this study, RAPN did not have a specific coding. The investigators had contacted the hospitals with Vinci robotic surgical procedures in 2013 and the investigators included here PN from hospitalisations from the 25 centres using exclusively RAPN for more than five years. Thus, in this study, RAPN was performed by experts in robotic surgery. Receives: Procedure: partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative complication
Complications were documented for the initial hospitalisation and any subsequent re-hospitalisation
Measured: 2 years
Secondary outcomes (1)
length of initial hospitalisation
length of initial hospitalisation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start1 Jan 2016
- Primary completion1 Jan 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 7,664 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESCHWEGE Pascal, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168761
- Sponsor's protocol ID
- 2040/1205
- Status last verified
- Dec 2021
- First submitted
- 9 Dec 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ljungberg B, Albiges L, Abu-Ghanem Y, Bensalah K, Dabestani S, Fernandez-Pello S, Giles RH, Hofmann F, Hora M, Kuczyk MA, Kuusk T, Lam TB, Marconi L, Merseburger AS, Powles T, Staehler M, Tahbaz R, Volpe A, Bex A. European Association of Urology Guidelines on Renal Cell Carcinoma: The 2019 Update. Eur Urol. 2019 May;75(5):799-810. doi: 10.1016/j.eururo.2019.02.011. Epub 2019 Feb 23.
PubMed 30803729Hanzly M, Frederick A, Creighton T, Atwood K, Mehedint D, Kauffman EC, Kim HL, Schwaab T. Learning curves for robot-assisted and laparoscopic partial nephrectomy. J Endourol. 2015 Mar;29(3):297-303. doi: 10.1089/end.2014.0303. Epub 2014 Oct 21.
PubMed 25111313Gill IS, Kavoussi LR, Lane BR, Blute ML, Babineau D, Colombo JR Jr, Frank I, Permpongkosol S, Weight CJ, Kaouk JH, Kattan MW, Novick AC. Comparison of 1,800 laparoscopic and open partial nephrectomies for single renal tumors. J Urol. 2007 Jul;178(1):41-6. doi: 10.1016/j.juro.2007.03.038. Epub 2007 May 11.
PubMed 17574056Masson-Lecomte A, Bensalah K, Seringe E, Vaessen C, de la Taille A, Doumerc N, Rischmann P, Bruyere F, Soustelle L, Droupy S, Roupret M. A prospective comparison of surgical and pathological outcomes obtained after robot-assisted or pure laparoscopic partial nephrectomy in moderate to complex renal tumours: results from a French multicentre collaborative study. BJU Int. 2013 Feb;111(2):256-63. doi: 10.1111/j.1464-410X.2012.11528.x. Epub 2012 Dec 20.
PubMed 23279002Bravi CA, Larcher A, Capitanio U, Mari A, Antonelli A, Artibani W, Barale M, Bertini R, Bove P, Brunocilla E, Da Pozzo L, Di Maida F, Fiori C, Gontero P, Li Marzi V, Longo N, Mirone V, Montanari E, Porpiglia F, Schiavina R, Schips L, Simeone C, Siracusano S, Terrone C, Trombetta C, Volpe A, Montorsi F, Ficarra V, Carini M, Minervini A. Perioperative Outcomes of Open, Laparoscopic, and Robotic Partial Nephrectomy: A Prospective Multicenter Observational Study (The RECORd 2 Project). Eur Urol Focus. 2021 Mar;7(2):390-396. doi: 10.1016/j.euf.2019.10.013. Epub 2019 Nov 12.
PubMed 31727523Haute Autorité de Santé HAS. Évaluation de la néphrectomie totale ou partielle assistée par robot.; 2019. https://www.has-sante.fr/jcms/p_3103989/fr/evaluation-de-la-nephrectomie-totale-ou-partielle-assistee-par-robot
Andersen MH, Mathisen L, Oyen O, Edwin B, Digernes R, Kvarstein G, Tonnessen TI, Wahl AK, Hanestad BR, Fosse E. Postoperative pain and convalescence in living kidney donors-laparoscopic versus open donor nephrectomy: a randomized study. Am J Transplant. 2006 Jun;6(6):1438-43. doi: 10.1111/j.1600-6143.2006.01301.x.
PubMed 16686768Camp C, O'Hara J, Hughes D, Adshead J. Short-term Outcomes and Costs Following Partial Nephrectomy in England: A Population-based Study. Eur Urol Focus. 2018 Jul;4(4):579-585. doi: 10.1016/j.euf.2017.03.010. Epub 2017 Apr 8.
PubMed 28753878Jain S, Nyirenda T, Yates J, Munver R. Incidence of renal artery pseudoaneurysm following open and minimally invasive partial nephrectomy: a systematic review and comparative analysis. J Urol. 2013 May;189(5):1643-8. doi: 10.1016/j.juro.2012.11.170. Epub 2012 Dec 3.
PubMed 23219544Peyronnet B, Seisen T, Oger E, Vaessen C, Grassano Y, Benoit T, Carrouget J, Pradere B, Khene Z, Giwerc A, Mathieu R, Beauval JB, Nouhaud FX, Bigot P, Doumerc N, Bernhard JC, Mejean A, Patard JJ, Shariat S, Roupret M, Bensalah K; French Comittee of Urologic Oncology (CCAFU). Comparison of 1800 Robotic and Open Partial Nephrectomies for Renal Tumors. Ann Surg Oncol. 2016 Dec;23(13):4277-4283. doi: 10.1245/s10434-016-5411-0. Epub 2016 Jul 13.
PubMed 27411552Zargar H, Khalifeh A, Autorino R, Akca O, Brandao LF, Laydner H, Krishnan J, Samarasekera D, Haber GP, Stein RJ, Kaouk JH. Urine leak in minimally invasive partial nephrectomy: analysis of risk factors and role of intraoperative ureteral catheterization. Int Braz J Urol. 2014 Nov-Dec;40(6):763-71. doi: 10.1590/S1677-5538.IBJU.2014.06.07.
PubMed 25615258Schmid M, Chiang HA, Sood A, Campbell L, Chun FK, Dalela D, Okwara J, Sammon JD, Kibel AS, Menon M, Fisch M, Trinh QD. Causes of hospital readmissions after urologic cancer surgery. Urol Oncol. 2016 May;34(5):236.e1-11. doi: 10.1016/j.urolonc.2015.11.019. Epub 2015 Dec 23.
PubMed 26712365Achit H, Guillemin F, Karam G, Ladriere M, Baumann C, Frimat L, Hosseini K, Hubert J. Cost-effectiveness of four living-donor nephrectomy techniques from a hospital perspective. Nephrol Dial Transplant. 2020 Nov 1;35(11):2004-2012. doi: 10.1093/ndt/gfz143.
PubMed 31377771Ficarra V, Novara G, Secco S, Macchi V, Porzionato A, De Caro R, Artibani W. Preoperative aspects and dimensions used for an anatomical (PADUA) classification of renal tumours in patients who are candidates for nephron-sparing surgery. Eur Urol. 2009 Nov;56(5):786-93. doi: 10.1016/j.eururo.2009.07.040. Epub 2009 Aug 4.
PubMed 19665284Patel HD, Mullins JK, Pierorazio PM, Jayram G, Cohen JE, Matlaga BR, Allaf ME. Trends in renal surgery: robotic technology is associated with increased use of partial nephrectomy. J Urol. 2013 Apr;189(4):1229-35. doi: 10.1016/j.juro.2012.10.024. Epub 2012 Oct 17.
PubMed 23085300
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications Associated With Partial Nephrectomy for Renal Cancer: PMSI French National Data
- ClinicalTrials.gov ID
- NCT05168761
- Acronym / sponsor ID
- 2040/1205
- Conditions
- Renal Cancer, Partial Nephrectomy
- Keywords
- nephron sparing, robot, PMSI, laparoscopy, open surgery, nephron sparing surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,664 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 23 Dec 2021 (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.
This paper evaluates the initial complications and the complications two years postoperatively necessitating re-hospitalisation for three surgical procedures for renal tumour partial nephrectomy .
Detailed description
This paper evaluates the initial complications and the complications two years postoperatively necessitating re-hospitalisation for three surgical procedures for renal tumour partial nephrectomy (open (OPN), standard laparoscopy (LPN) and robot assisted laparoscopy (RAPN)) in 2016-2017 in France (9119 initial hospitalisations included 4035 OPN, 1900 RAPN, 1709 LPN). The investigators have extracted for these all hospitalisations from the French national hospital data base (PMSI-MCO). The investigators concluded mini-invasive and robotic surgery had lower morbidity and a shorter initial hospitalisation.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| laparoscopic partial nephrectomy | – | Procedure: partial nephrectomyThe investigators included all hospitalisations for LPN using CCAM(Classification Commune des actes médicaux) code (JAFC005) after removing the 83 hospitals using RAPN in 2017. LPN complications were from hospitals using exclusively LPN. |
| open partial nephrectomy | – | Procedure: partial nephrectomyOPN has its own CCAM codes; they group laparotomy (JAFA019 / JAFA030) and lumbotomy (JAFA008 / JAFA024) |
| robot assisted partial nephrectomy | – | Procedure: partial nephrectomyAt the time of this study, RAPN did not have a specific coding. The investigators had contacted the hospitals with Vinci robotic surgical procedures in 2013 and the investigators included here PN from hospitalisations from the 25 centres using exclusively RAPN for more than five years. Thus, in this study, RAPN was performed by experts in robotic surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In total, there were 11,698 hospitalisations between the 1st January 2016 and the 31st December 2017 with one of the PN codes from the Classification Commune des Actes Médicaux (CCAM) (Annex 1). The investigators used a supplementary filter for the diagnosis of renal cancer, C64, from the International Classification of Diseases 10th edition (ICD-10). The Department of Medical Informatics, Nancy CHRU controlled coding discrepancies, leaving 9119 hospitalisations for study
Key inclusion criteria (1 listed)
- hospitalisations between the 1st January 2016 and the 31st December 2017 with one of the partial nephrectomy codes
Key exclusion criteria (2 listed)
- partial nephrectomy for non-cancerous pathology
- no technical information
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 |
|---|---|---|
| partial nephrectomy | Procedure or surgery | laparoscopic partial nephrectomy, open partial nephrectomy, robot assisted partial nephrectomy |
Primary outcome
post operative complication
Time frame: 2 years
Complications were documented for the initial hospitalisation and any subsequent re-hospitalisation
1 secondary outcome
length of initial hospitalisation
Time frame: 2 years
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 13 Jan 2022.
- Background: PubMed 30803729Ljungberg B, Albiges L, Abu-Ghanem Y, Bensalah K, Dabestani S, Fernandez-Pello S, Giles RH, Hofmann F, Hora M, Kuczyk MA, Kuusk T, Lam TB, Marconi L, Merseburger AS, Powles T, Staehler M, Tahbaz R, Volpe A, Bex A. European Association of Urology Guidelines on Renal Cell Carcinoma: The 2019 Update. Eur Urol. 2019 May;75(5):799-810. doi: 10.1016/j.eururo.2019.02.011. Epub 2019 Feb 23.
- Background: PubMed 25111313Hanzly M, Frederick A, Creighton T, Atwood K, Mehedint D, Kauffman EC, Kim HL, Schwaab T. Learning curves for robot-assisted and laparoscopic partial nephrectomy. J Endourol. 2015 Mar;29(3):297-303. doi: 10.1089/end.2014.0303. Epub 2014 Oct 21.
- Background: PubMed 17574056Gill IS, Kavoussi LR, Lane BR, Blute ML, Babineau D, Colombo JR Jr, Frank I, Permpongkosol S, Weight CJ, Kaouk JH, Kattan MW, Novick AC. Comparison of 1,800 laparoscopic and open partial nephrectomies for single renal tumors. J Urol. 2007 Jul;178(1):41-6. doi: 10.1016/j.juro.2007.03.038. Epub 2007 May 11.
- Background: PubMed 23279002Masson-Lecomte A, Bensalah K, Seringe E, Vaessen C, de la Taille A, Doumerc N, Rischmann P, Bruyere F, Soustelle L, Droupy S, Roupret M. A prospective comparison of surgical and pathological outcomes obtained after robot-assisted or pure laparoscopic partial nephrectomy in moderate to complex renal tumours: results from a French multicentre collaborative study. BJU Int. 2013 Feb;111(2):256-63. doi: 10.1111/j.1464-410X.2012.11528.x. Epub 2012 Dec 20.
- Background: PubMed 31727523Bravi CA, Larcher A, Capitanio U, Mari A, Antonelli A, Artibani W, Barale M, Bertini R, Bove P, Brunocilla E, Da Pozzo L, Di Maida F, Fiori C, Gontero P, Li Marzi V, Longo N, Mirone V, Montanari E, Porpiglia F, Schiavina R, Schips L, Simeone C, Siracusano S, Terrone C, Trombetta C, Volpe A, Montorsi F, Ficarra V, Carini M, Minervini A. Perioperative Outcomes of Open, Laparoscopic, and Robotic Partial Nephrectomy: A Prospective Multicenter Observational Study (The RECORd 2 Project). Eur Urol Focus. 2021 Mar;7(2):390-396. doi: 10.1016/j.euf.2019.10.013. Epub 2019 Nov 12.
- BackgroundHaute Autorité de Santé HAS. Évaluation de la néphrectomie totale ou partielle assistée par robot.; 2019. https://www.has-sante.fr/jcms/p_3103989/fr/evaluation-de-la-nephrectomie-totale-ou-partielle-assistee-par-robot
- Background: PubMed 16686768Andersen MH, Mathisen L, Oyen O, Edwin B, Digernes R, Kvarstein G, Tonnessen TI, Wahl AK, Hanestad BR, Fosse E. Postoperative pain and convalescence in living kidney donors-laparoscopic versus open donor nephrectomy: a randomized study. Am J Transplant. 2006 Jun;6(6):1438-43. doi: 10.1111/j.1600-6143.2006.01301.x.
- Background: PubMed 28753878Camp C, O'Hara J, Hughes D, Adshead J. Short-term Outcomes and Costs Following Partial Nephrectomy in England: A Population-based Study. Eur Urol Focus. 2018 Jul;4(4):579-585. doi: 10.1016/j.euf.2017.03.010. Epub 2017 Apr 8.
- Background: PubMed 23219544Jain S, Nyirenda T, Yates J, Munver R. Incidence of renal artery pseudoaneurysm following open and minimally invasive partial nephrectomy: a systematic review and comparative analysis. J Urol. 2013 May;189(5):1643-8. doi: 10.1016/j.juro.2012.11.170. Epub 2012 Dec 3.
- Background: PubMed 27411552Peyronnet B, Seisen T, Oger E, Vaessen C, Grassano Y, Benoit T, Carrouget J, Pradere B, Khene Z, Giwerc A, Mathieu R, Beauval JB, Nouhaud FX, Bigot P, Doumerc N, Bernhard JC, Mejean A, Patard JJ, Shariat S, Roupret M, Bensalah K; French Comittee of Urologic Oncology (CCAFU). Comparison of 1800 Robotic and Open Partial Nephrectomies for Renal Tumors. Ann Surg Oncol. 2016 Dec;23(13):4277-4283. doi: 10.1245/s10434-016-5411-0. Epub 2016 Jul 13.
- Background: PubMed 25615258Zargar H, Khalifeh A, Autorino R, Akca O, Brandao LF, Laydner H, Krishnan J, Samarasekera D, Haber GP, Stein RJ, Kaouk JH. Urine leak in minimally invasive partial nephrectomy: analysis of risk factors and role of intraoperative ureteral catheterization. Int Braz J Urol. 2014 Nov-Dec;40(6):763-71. doi: 10.1590/S1677-5538.IBJU.2014.06.07.
- Background: PubMed 26712365Schmid M, Chiang HA, Sood A, Campbell L, Chun FK, Dalela D, Okwara J, Sammon JD, Kibel AS, Menon M, Fisch M, Trinh QD. Causes of hospital readmissions after urologic cancer surgery. Urol Oncol. 2016 May;34(5):236.e1-11. doi: 10.1016/j.urolonc.2015.11.019. Epub 2015 Dec 23.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cancer and Partial Nephrectomy, run by Central Hospital, Nancy, 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 1 inclusion and 2 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 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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 complication (time frame: 2 years). 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 NCT05168761, which also lists 17 linked publications.
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 13 Jan 2022.