Clinical trial · Interventional
3D Versus Robot Assisted Laparoscopic Prostatectomy.
3D Versus Robot Assisted Laparoscopic Prostatectomy. A Prospective Randomized Non-inferiority Study.
NCT03550040CI-TRIAL-00071659terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): accrual was sufficient at interim analysis to draw final conclusions needed to publish
Summary
Brief summary (as posted)
A randomized, prospective study to compare the direct and indirect costs, functional and oncologic results of 3D laparoscopic and robot assisted radical prostatectomy procedures.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radical prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Robot assisted prostatectomy.
- description
- Intervention: radical prostatectomy
- interventionNames
- Procedure: Radical prostatectomy
- type
- EXPERIMENTAL
- label
- 3D laparoscopic prostatectomy
- description
- Intervention: radical prostatectomy
- interventionNames
- Procedure: Radical prostatectomy
Primary outcomes (1)
- measure
- Urinary continence
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 34 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Localized prostate cancer undergoing radical prostatectomy * Patient has to understand and be able to write and read Finnish language * No prior head injury, dementia or Parkinson's disease * No concomitant malignant illness * Life expectancy of at least 10 years * 35-74 years of age Exclusion Criteria: * Locally advanced prostate cancer (T4) * Suspicion or documented metastases (M1) * Serum PSA \> 20 ng/ml * Prior laparoscopic hernia surgery employing non resorbable mesh * Prior pelvic irradiation or major surgery * Prior malignant disease within prior 5 years excluding skin cancer (non-melanoma).
References
Publications (0)
Data not yet available
No reference posted for this study.