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| ID | Type | Description | Link |
|---|---|---|---|
| 110462 | Other Grant/Funding Number | Deutsche Krebshilfe |
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| Name | Class |
|---|---|
| Klinikum Dortmund | UNKNOWN |
| University Hospital Heidelberg | OTHER |
| Heinrich-Heine University, Duesseldorf | OTHER |
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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.
LAP-01 is the first multicenter, prospective randomized, patient-blinded controlled trial comparing robotic-assisted and conventional laparoscopic radical prostatectomy.
The investigation include an extensive evaluation of clinical, oncological, functional and quality of life related data by means of validated patient-reported outcome measures.
The primary outcome is the assessment of time to continence restoration at 3 months. This is evaluated by an assessment of a pad diary completed daily by each patient from the time of catheter removal until restoration of continence. Secondary endpoints include continence and erectile function, as well as quality of life (EORTC-QLQ-C30, EORTC-QLQ-PR25), patient satisfaction and Hospital Anxiety and Depression Scale (HADS) at 1, 3, 6 and 12 months after surgery in addition to oncological outcomes up to 3 years follow-up.
With 782 enrolled patients it is the largest trial carried out till date on this topic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RARP | Other | robot-assisted laparoscopic prostatectomy |
|
| LRP | Other | conventional laparoscopic radical prostatectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostatectomy | Procedure | Comparison of robotic-assisted and conventional laparoscopic radical prostatectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early Continence | The primary outcome is continence recovery at 3 months based on the patient's pad diary; RARP vs. LRP | 3 months after removal of the urinary catheter |
| Measure | Description | Time Frame |
|---|---|---|
| Continence | Continence (pad use/day) | 1, 3, 6, 12 months postoperative |
| Continence | Continence (ICIQ-SF scores) | 1, 3, 6, 12 months postoperative |
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Inclusion criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens-Uwe Stolzenburg, Prof. | Leipzig University, Department of Urology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Dortmund | Dortmund | 44137 | Germany | |||
| Universitätsklinikum Düsseldorf |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38238789 | Derived | Holze 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. | |
| 35124734 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 27, 2014 | Sep 9, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011468 | Prostatectomy |
| ID | Term |
|---|---|
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Patients were blinded with respect to the surgical method until the end of the 3-month evaluation and extraction of the primary study outcome.
| Erectile function | Erectile function questionnaire (including IIEF-5 questionnaire) and information on supportive medication for erection | 1, 3, 6, 12 months postoperative |
| Health-related quality of life of patients | Health-related quality of life questionnaire (EORTC QLQ-C30). Raw scores are linearly transformed into a 0-100 point scale. High global health status and functioning scores indicate good QoL, whereas elevated symptom scores represent a high level of symptomology and therefore impaired QoL. | 1, 3, 6, 12 months postoperative |
| Prostate-specific quality of life of patients | Prostate-specific quality of life questionnaire (EORTC QLQ-PR25). Raw scores are linearly transformed into a 0-100 point scale. High functioning scores indicate good QoL, whereas elevated symptom scores represent a high level of symptomology and therefore impaired QoL. | 1, 3, 6, 12 months postoperative |
| Anxiety and depression assessment | The Hospital Anxiety and Depression Scales (HADS-D) | 1, 3, 6, 12 months postoperative |
| Patient satisfaction | Patient satisfaction is measured on a 5-point scale ranging from highly dissatisfied to highly satisfied. Additionally, patients are asked if they would in hindsight make a decision for or against the surgery and if they would advise a friend to undergo surgery under the same circumstances. | 1, 3, 6, 12 months postoperative |
| PSA (prostate-specific antigen) | PSA (prostate-specific antigen) | 1, 3, 6, 12, 24, 36 months postoperative |
| Rate of relapse and metastases | Relapse and metastases | 1, 3, 6, 12, 24, 36 months postoperative |
| Rate of patients with further anti-cancer therapy | Further anti-cancer therapy | 1, 3, 6, 12, 24, 36 months postoperative |
| Time of surgery | time of surgery | measured as time from starting the surgical procedure in the DaVinci console to ending the procedure in the console |
| Tumor Resection | Tumor Resection | during surgery |
| Intra-operative parameters | Rate of Complications | during surgery |
| Düsseldorf |
| 40225 |
| Germany |
| University Hospital Heidelberg | Heidelberg | 69120 | Germany |
| University of Leipzig | Leipzig | 04103 | Germany |
| Holze 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. |
| 33573861 | Derived | Stolzenburg 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |