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Recruiting

NCT Number: NCT05975775

Outpatient Laparoscopic Radical Prostatectomy

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Clinique de la Sauvegarde

Lyon, 69009, France

Location status: Recruiting

Location contact

Arnaud BALDINI, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Laparoscopic Radical Prostatectomy

Procedure

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

Primary outcomes

  1. Incidence of complications

    Time frame: 30 days

    The primary endpoint was the incidence of procedural complications between Day 0 and Day 30.

Study contacts

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

Arnaud BALDINI, MD

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

Acronym: LORP

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 4, 2023
Registry last updated
Mar 30, 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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