Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
782 participants
INTERVENTIONAL
2014-11-30
2021-12-31
Brief Summary
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Purpose: The LAP-01 trial compares outcomes between RARP and LRP.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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RARP
robot-assisted laparoscopic prostatectomy
Prostatectomy
Comparison of robotic-assisted and conventional laparoscopic radical prostatectomy
LRP
conventional laparoscopic radical prostatectomy
Prostatectomy
Comparison of robotic-assisted and conventional laparoscopic radical prostatectomy
Interventions
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Prostatectomy
Comparison of robotic-assisted and conventional laparoscopic radical prostatectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
MALE
No
Sponsors
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Klinikum Dortmund
UNKNOWN
University Hospital Heidelberg
OTHER
Heinrich-Heine University, Duesseldorf
OTHER
University of Leipzig
OTHER
Responsible Party
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Jens-Uwe Stolzenburg
Prof.
Principal Investigators
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Jens-Uwe Stolzenburg, Prof.
Role: PRINCIPAL_INVESTIGATOR
Leipzig University, Department of Urology
Locations
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Klinikum Dortmund
Dortmund, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
University Hospital Heidelberg
Heidelberg, , Germany
University of Leipzig
Leipzig, , Germany
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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LAP-01
Identifier Type: -
Identifier Source: org_study_id
110462
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id