Complications Associated With Partial Nephrectomy for Renal Cancer

December 24, 2021 updated by: ESCHWEGE Pascal, Central Hospital, Nancy, France

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

7664

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative complication
Time Frame: 2 years
Complications were documented for the initial hospitalisation and any subsequent re-hospitalisation
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of initial hospitalisation
Time Frame: 2 years
length of initial hospitalisation
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

December 9, 2021

First Submitted That Met QC Criteria

December 9, 2021

First Posted (Actual)

December 23, 2021

Study Record Updates

Last Update Posted (Actual)

January 13, 2022

Last Update Submitted That Met QC Criteria

December 24, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2040/1205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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