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Randomized, multicenter study comparing robotic-assisted and conventional laparoscopic radical prostatectomy

Randomized, multicenter study comparing robotic-assisted and conventional laparoscopic radical prostatectomy - LAP-01

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00007138
Enrollment
782
Registered
2014-11-13
Start date
2014-11-17
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C61

Interventions

Group 1: conventional laparoscopic radical prostatectomy Group 2: robotic-assisted laparoscopic radical prostatectomy

Sponsors

Universität Leipzig
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: - Histologically confirmed prostate cancer (diagnosis) - Indication for primary-curative radical prostatectomy - Patients aged = 75 years (at the time of surgery)

Exclusion criteria

Exclusion criteria: - Obese patients with a BMI> 35 - Currently present severe concomitant disease (eg, Liver cirrhosis, secondary malignancy or recurrence of any kind) - Tumor stage: T4 - Previous malignancy (= 3 years before inclusion in this study) - Neoadjuvant therapy (= 3 months prior to inclusion in this study) - Immune Compromised Patients - Intermittent self-catheterization (in the year prior consent) - The following treatments in the past 3 months: Operations at Sigma, extensive Hämorrhoidalresektion, Transurethral needle ablation of the prostate (TUNA), osteosynthesis supplies the pelvic area, salvage prostatectomy - Patients with chronic urinary tract infection (proven more than 5 antibiotic-requiring infection episodes in last year) - Requiring dialysis patients

Design outcomes

Primary

MeasureTime frame
continence 3 months postoperative (ICIQ=Urinary Incontinence Form, pads, pad diary)

Secondary

MeasureTime frame
- Continence (ICIQ-SF): 1, 3, 6, 12 months p.o. - Continence (Pads-per day): 1, 6, 12 months p.o. - Erectile function (IIEF-5): 3, 6, 12 months p.o. - Quality of life (EORTC QLQ-C30): 1, 3, 6, 12 months p.o. - Anxiety and depression (HADS): 1, 3, 6, 12 months p.o. - Satisfaction: 1, 3, 6, 12 months p.o. - PSA: 3, 6, 12, 24, 36

Countries

Germany

Contacts

Public ContactSigrun Holze

Universitätsklinikum Leipzig, Klinik und Poliklinik für Urologie

LAP-01@uniklinik-leipzig.de03419717600

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 13, 2026