Study of Post-operative Complications After Laparoscopic Outpatient Nephrectomy (NEPHRAMBU)

March 27, 2026 updated by: GCS Ramsay Santé pour l'Enseignement et la Recherche

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Adult patients diagnosed with localised kidney cancer, undergoing scheduled surgery for partial or total laparoscopic nephrectomy on an outpatient basis.

Description

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).

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
cohort of outpatients
Adult patients diagnosed with localised kidney cancer, undergoing scheduled surgery for partial or total laparoscopic nephrectomy on an outpatient basis.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Collaborators and Investigators

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

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Collaborators

Euraxi Pharma

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)

December 13, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-A02569-36

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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