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Recruiting NCT06532422

Study of Post-operative Complications After Laparoscopic Outpatient Nephrectomy

Observational Kidney Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Partial or total laparoscopic nephrectomy.
Who it may be relevant to
Registry conditions: Kidney Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Study of Post-operative Complications After Laparoscopic Outpatient Nephrectomy in Patients With Localised Kidney Cancer

Overview

The purpose of this study is to compare to assess the incidence of post-operative complications related to nephrectomy, which occur up to 1 month after the operation.

Detailed description

This is an observational, prospective, open, non-comparative (single arm), single-centre study.

The study population consisted of adult patients diagnosed with localised kidney cancer and scheduled for outpatient partial or total laparoscopic nephrectomy.

Patients eligible for outpatient surgery will be identified during the initial consultation with the urological surgeon. When the indication for surgery has been validated at the multidisciplinary consultation meeting and is planned to be performed as an outpatient procedure, the study will be proposed to the patient by the investigator during the preoperative consultation.

Interventions

  • Procedure Partial or total laparoscopic nephrectomy
    Nephrectomy is currently the primary indication for localised kidney cancer. All patients consulting a surgeon at the Clinique de la Sauvegarde for localised kidney cancer, for which surgical excision has been validated by the multidisciplinary consultation meeting and who are eligible for outpatient treatment, will be offered the opportunity to take part in this study during the preoperative consultation.

Primary outcome measures

  • Incidence of complications [Time frame: 1 month]

Eligibility criteria

Inclusion criteria

  • Patients over 18 ;
  • Localised kidney cancer ;
  • Validation of curative treatment at a multidisciplinary consultation meeting;
  • Partial or total laparoscopic nephrectomy scheduled on an outpatient basis;
  • Membership of a social security scheme or receiving State Medical Aid;
  • Patient able to understand the information relating to the study, to read the information leaflet and who has given his/her oral non-objection.

Exclusion criteria

  • Emergency intervention ;
  • Patient not eligible for outpatient treatment;
  • Long-term curative anti-coagulant treatment ;
  • Resident more than 100km from the clinic;
  • Home alone on the first night;
  • Patient of protected age (under guardianship or curatorship, or deprived of liberty).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Clinique de la Sauvegarde — Lyon

Identifiers

NCT: NCT06532422 · 2023-A02569-36

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗