Clinical trial · Interventional
Laparoscopic vs Robotic-Assisted Radical Prostatectomy
A Multicenter Randomized Study to Investigate the Outcomes of Laparoscopic and Robotic-assisted Radical Prostatectomy
NCT03682146CI-TRIAL-00071828LAP-01completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This randomized trial was designed to address the lack of high-quality literature comparing robotic-assisted (RARP) and laparoscopic (LRP) radical prostatectomy (RP). Purpose: The LAP-01 trial compares outcomes between RARP and LRP.
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 |
|---|---|---|---|
| Prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- RARP
- description
- robot-assisted laparoscopic prostatectomy
- interventionNames
- Procedure: Prostatectomy
- type
- OTHER
- label
- LRP
- description
- conventional laparoscopic radical prostatectomy
- interventionNames
- Procedure: Prostatectomy
Primary outcomes (1)
- measure
- Early Continence
- timeFrame
- 3 months after removal of the urinary catheter
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion criteria * Histological verified prostate carcinoma (first diagnosis) * Indication for primary curative radical prostatectomy * Age ≤ 75 years * Patient agrees to randomisation * Patient is able to fill in the questionnaires on his own * Patient is willing to provide written informed consent Exclusion Criteria: * Insufficient knowledge of German * Severe cognitive impairment * Obesity (BMI \> 35) * Current existing severe comorbidities (e.g. liver cirrhosis, second malignancy or relapse of every kind) * Tumor stage: T4 * Previous malignancy (≤ 3 years before trial participation) * Neoadjuvant therapy (hormons) within the last 3 months before participation in the trial * Patient is immuno-compromised * History of intermittent urinary self-catheterization within the last year * Psychological disorders (dementia, chronic depression, psychosis) * Any of the following treatments ≤ 3 months before trial participation: surgery of the sigmoid colon, extended haemorrhoid resection, transurethral needle ablation of the prostate (TUNA), osteosynthesis of the pelvis, salvage prostatectomy * Patients with chronic urinary infection * Dialysis patients * Lacking willingness for data storage and handling in the frame of the trial protocol/aims
References
Publications (3)
- DERIVEDHolze S, Kuntze AS, Mende M, Neuhaus P, Truss MC, Do HM, Dietel A, Franz T, Stolzenburg JU. Assessment of different continence definitions in the context of the randomized multicenter prospective LAP-01 trial-Does the best definition change over time? Eur J Med Res. 2024 Jan 18;29(1):58. doi: 10.1186/s40001-024-01662-5. PMID 38238789
- DERIVEDHolze S, Braunlich M, Mende M, Arthanareeswaran VK, Neuhaus P, Truss MC, Do HM, Dietel A, Franz T, Teber D, Heilsberg AK, Hohenfellner M, Rabenalt R, Albers P, Stolzenburg JU. Age-stratified outcomes after radical prostatectomy in a randomized setting (LAP-01): do younger patients have more to lose? World J Urol. 2022 May;40(5):1151-1158. doi: 10.1007/s00345-022-03945-0. Epub 2022 Feb 6. PMID 35124734
- DERIVEDStolzenburg JU, Holze S, Neuhaus P, Kyriazis I, Do HM, Dietel A, Truss MC, Grzella CI, Teber D, Hohenfellner M, Rabenalt R, Albers P, Mende M. Robotic-assisted Versus Laparoscopic Surgery: Outcomes from the First Multicentre, Randomised, Patient-blinded Controlled Trial in Radical Prostatectomy (LAP-01). Eur Urol. 2021 Jun;79(6):750-759. doi: 10.1016/j.eururo.2021.01.030. Epub 2021 Feb 9. PMID 33573861