Study of Post-operative Complications After Laparoscopic Outpatient Nephrectomy

NCT ID: NCT06532422

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-13

Study Completion Date

2026-09-30

Brief Summary

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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

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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.

Conditions

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Kidney Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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cohort of outpatients

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

Partial or total laparoscopic nephrectomy

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role lead

Euraxi Pharma

INDUSTRY

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique de la Sauvegarde

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Arnaud MD BALDINI

Role: CONTACT

469001019 ext. +33

Facility Contacts

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Arnaud MD BALDINI

Role: primary

Other Identifiers

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2023-A02569-36

Identifier Type: -

Identifier Source: org_study_id

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