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Outpatient Laparoscopic Radical Prostatectomy

Study of Postoperative Complications After Laparoscopic Outpatient Radical Prostatectomy in Patients With Localized Prostate Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05975775
Acronym
LORP
Enrollment
64
Registered
2023-08-04
Start date
2023-10-20
Completion date
2026-10-01
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief summary

The purpose of the study is to evaluate the incidence of surgery-related complications between Day 0 and Day 30.

Detailed description

This is an observational, prospective, open, non-comparative (single arm), bicentric study. This study is aimed at patients with prostate cancer for whom an ambulatory laparoscopic radical prostatectomy has been validated at a multidisciplinary consultation meeting. The possibility of performing this procedure on an outpatient basis is left to the surgeon's discretion, according to well-defined medical procedure criteria. This cohort is part of the usual care. The study will observe the incidence and describe the type, number, severity, duration and frequency of procedure-related complications that may arise in the first month post-op of ambulatory Laparoscopic Radical Prostatectomy. For this reason, patient follow-up will stop at 1 month after surgery, during a routine follow-up visit.

Interventions

Prostate cancer may require laparoscopic radical prostatectomy, a surgical procedure performed under general anaesthetic.

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead SponsorOTHER
Euraxi Pharma
CollaboratorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Male, age ≥ 18 years; * Localized prostate cancer; * Validation in a multidisciplinary consultation meeting of curative treatment; * Scheduled laparoscopic radical prostatectomy; * Patient able to understand the information related to the study, to read the information leaflet and to signify his/her non-opposition or opposition to participating in the study; * Membership of a social security scheme; * Patient having been informed and having given oral non-opposition.

Exclusion criteria

* Surgical emergency; * Patient not eligible for ambulatory care; * Long-term curative anti-coagulant treatment; * Resident more than 100km from the clinic; * Home alone the first night; * Patient under guardianship, curatorship or deprivation of liberty.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of complications30 daysThe primary endpoint was the incidence of procedural complications between Day 0 and Day 30.

Countries

France

Contacts

CONTACTArnaud BALDINI, MD
docteur.baldini@urolyon-ouest.fr469001019

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026