Study of Post-operative Complications After Laparoscopic Outpatient Nephrectomy

NCT06532422 | Recruiting

• 1 other identifier: 2023-A02569-36
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of complications

  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

Study Arms (1)

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

Interventions

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.

cohort of outpatients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Euraxi Pharma: collaborator
• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Clinique de la Sauvegarde

Lyon, 69009, France

RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Arnaud MD BALDINI

CONTACT

469001019; docteur.baldini@urolyon-ouest.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: December 13, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

FR (1)