Clinical trial · Interventional
Cost Efficacy Evaluation of Robot Assisted Radical Prostatectomy
Medico-economic Evaluation of Robotic-assisted Radical Prostatectomy Versus Laparoscopic Radical Prostatectomy
- 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)
In this observational cost efficacy study, the investigator compare the Laparoscopic Radical Prostatectomy (LRP) versus Robotic-Assisted Laparoscopic Prostatectomy (RALP). Every cost of care that include hospitalization related or post operative medical consumption are obtained and recorded up to 5 years follow up. Functional results (continence, potency, quality of life) are obtained through standardised questionnaires. Carcinologic results are estimated by Prostate Specific Antigen (PSA) relapse and salvage treatments. Economic evaluation will be made to estimate direct costs of the four postoperative year along with the incremental cost-effectiveness ratio (ICER) per successful surgical treatment (preserved urinary continence and erectile function and PSA \< 0.2).
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic Radical Prostatectomy | Procedure | — | UNRESOLVED |
| Robotic-Assisted Radical Prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Robotic-Assisted Radical Prostatectomy
- description
- Robotic-Assisted Radical Prostatectomy using da Vinci Surgical System
- interventionNames
- Procedure: Robotic-Assisted Radical Prostatectomy
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopic Radical Prostatectomy
- description
- Standard laparoscopic Radical Prostatectomy
- interventionNames
- Procedure: Laparoscopic Radical Prostatectomy
Primary outcomes (1)
- measure
- Erectile function
- timeFrame
- 12 months after surgery
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Localized prostate cancer * Gleason grade ≤ 3 + 4 * PSA \< 15 ng / mL * Stage ≤ T2b * Eligible to receive laparoscopic radical prostatectomy * Candidate bilateral or unilateral erectile preservation Exclusion Criteria: * Patient at high risk of postoperative progression (PSA\> 15 ng / mL; grade 5 predominant, clinical or radiological stage T3 * Presenting erectile dysfunction (IIEF \< 22) * Past history of urinary incontinence (\> grade 1 WHO) * Body mass index \> 30
References
Publications (0)
Data not yet available