NCT05168761

Brief 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 .

Trial Health

100
On Track

Trial Health Score

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

Enrollment
7,664

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

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

January 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 23, 2021

Completed
Last Updated

January 13, 2022

Status Verified

December 1, 2021

Enrollment Period

2 years

First QC Date

December 9, 2021

Last Update Submit

December 24, 2021

Conditions

Keywords

nephron sparingrobotPMSIlaparoscopyopen surgerynephron sparing surgery

Outcome Measures

Primary Outcomes (1)

  • post operative complication

    Complications were documented for the initial hospitalisation and any subsequent re-hospitalisation

    2 years

Secondary Outcomes (1)

  • length of initial hospitalisation

    2 years

Study Arms (3)

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.

Procedure: partial nephrectomy

open partial nephrectomy

OPN has its own CCAM codes; they group laparotomy (JAFA019 / JAFA030) and lumbotomy (JAFA008 / JAFA024)

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.

Procedure: partial nephrectomy

Interventions

laparoscopic partial nephrectomyopen partial nephrectomyrobot assisted partial nephrectomy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • hospitalisations between the 1st January 2016 and the 31st December 2017 with one of the partial nephrectomy codes

You may not qualify if:

  • partial nephrectomy for non-cancerous pathology
  • no technical information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (17)

  • 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.

    PMID: 30803729BACKGROUND
  • Hanzly 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.

    PMID: 25111313BACKGROUND
  • Gill 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.

    PMID: 17574056BACKGROUND
  • Masson-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.

    PMID: 23279002BACKGROUND
  • Bravi 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.

    PMID: 31727523BACKGROUND
  • Haute 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
  • 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.

    PMID: 16686768BACKGROUND
  • Camp 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.

    PMID: 28753878BACKGROUND
  • Jain 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.

    PMID: 23219544BACKGROUND
  • Peyronnet 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.

    PMID: 27411552BACKGROUND
  • Zargar 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.

    PMID: 25615258BACKGROUND
  • Schmid 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.

    PMID: 26712365BACKGROUND
  • Achit 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.

    PMID: 31377771BACKGROUND
  • Ficarra 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.

    PMID: 19665284BACKGROUND
  • Patel 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.

    PMID: 23085300BACKGROUND
  • Tikkinen KAO, Craigie S, Agarwal A, Violette PD, Novara G, Cartwright R, Naspro R, Siemieniuk RAC, Ali B, Eryuzlu L, Geraci J, Winkup J, Yoo D, Gould MK, Sandset PM, Guyatt GH. Procedure-specific Risks of Thrombosis and Bleeding in Urological Cancer Surgery: Systematic Review and Meta-analysis. Eur Urol. 2018 Feb;73(2):242-251. doi: 10.1016/j.eururo.2017.03.008. Epub 2017 Mar 23.

    PMID: 28342641BACKGROUND
  • Georgescu I, Hartmann FG. Sources of financial pressure and up coding behavior in French public hospitals. Health Policy. 2013 May;110(2-3):156-63. doi: 10.1016/j.healthpol.2013.02.003. Epub 2013 Mar 9.

    PMID: 23477807BACKGROUND

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 Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 9, 2021

First Posted

December 23, 2021

Study Start

January 1, 2016

Primary Completion

January 1, 2018

Study Completion

December 31, 2019

Last Updated

January 13, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share