Clinical trial · Interventional
Medico-economic Comparison of Robot-assisted Radical Prostatectomy Versus Radical Prostatectomy Via Laparotomy
Medico-economic Comparison of Robot-assisted Radical Prostatectomy Using the da Vinci System Versus Radical Prostatectomy Via Laparotomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main objective of the study is to estimate and compare the overall cost of care of patients over 60 months of follow-up between two groups: (1) patients undergoing robot-assisted radical prostatectomy using the Da Vinci system versus (2) patients undergoing robot-assisted radical prostatectomy via laparotomy. The time horizon of the main objective changes to 60 months (due to the opportunity to access patient care consumption from the National Health Data System).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radical prostatectomy via laparotomy | Procedure | — | UNRESOLVED |
| Robot-assisted radical prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Robotic assistance, Nîmes
- description
- The patients in this group will undergo robot-assisted radical prostatectomy at the University Hospital of Nîmes.
- interventionNames
- Procedure: Robot-assisted radical prostatectomy
- type
- ACTIVE_COMPARATOR
- label
- Laparotomy, Marseilles
- description
- The patients in this group will undergo radical prostatectomy via traditional laparotomy at the University Hospital Marseillles.
- interventionNames
- Procedure: Radical prostatectomy via laparotomy
Primary outcomes (1)
- measure
- Overall cost (€) of patient care
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * The patient must have given his informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * The patient is available for 24 months of follow up * Patient has localised prostate cancer * Patient is eligible for radical prostatectomy Exclusion Criteria: * The patient is participating in another study * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * Patient has a contraindication for a treatment necessary for this study * Patients with psychiatric disorders
References
Publications (1)
- RESULTBouvet S, Chkair S, Daures JP, Kabani S; OptiPRobot Study Group; Chevallier T, Lechevallier E, Droupy S. Robot-assisted approach versus open surgery and conventional laparoscopy for radical prostatectomy for prostate cancer: a micro-costing study. Health Econ Rev. 2025 Jul 5;15(1):55. doi: 10.1186/s13561-025-00652-5. PMID 40616606