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NCT Number: NCT06532422

Study of Post-operative Complications After Laparoscopic Outpatient Nephrectomy

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique de la Sauvegarde

Lyon, 69009, France

Location status: Recruiting

Location contact

Arnaud MD BALDINI

CONTACT

[email protected]

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Partial or total laparoscopic nephrectomy

Procedure

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 outcomes

  1. Incidence of complications

    Time frame: 1 month

    The study will observe the incidence and describe the type, number, severity, duration and frequency of complications that may arise in the immediate post-operative period following ambulatory nephrectomy.

Study contacts

Contact information is provided by the study sponsor or research team.

Arnaud MD BALDINI

CONTACT

[email protected]

469001019 ext. +33

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • Euraxi Pharma

Registry information

Official study title

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

Acronym: NEPHRAMBU

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2024
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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