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Peritoneal flap as Lymphocele prophylaxis following robotic-assisted (DaVinci ® System, Intuitive Surgical®), laparoscopic radical prostatectomy with pelvic lymph node dissection

Peritoneal flap as Lymphocele prophylaxis following robotic-assisted (DaVinci ® System, Intuitive Surgical®), laparoscopic radical prostatectomy with pelvic lymph node dissection - PELYCAN

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
DRKS
Registry ID
DRKS00016794
Enrollment
537
Registered
2019-05-13
Start date
2019-09-02
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 I89.8

Interventions

Group 1: robotic-assisted (DaVinci ® System, Intuitive Surgical®), laparoscopic radical prostatectomy with pelvic lymph node dissection WITH peritoneal flap Group 2: robotic-assisted (DaVinci ® System

Sponsors

Universitätsklinikum Mannheim
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: patients undergoing robotic-assisted, laproscopic prostatectomy with pelvic lymph node dissection; Low, intermediate and high-risk (D’Amico); age = 18 years; written informed consent

Exclusion criteria

Exclusion criteria: - former transperitoneal hernia repair - metastatic disease - dementia or psychiatric disease - former radiation of the pelvis or pelvic surgery - insufficient knowledge of German

Design outcomes

Primary

MeasureTime frame
Symptomatic pelvic lymphocele within 6 months after robotic-assisted (DaVinci ® System, Intuitive Surgical®), laparoscopic radical prostatectomy with pelvic lymph node dissection

Secondary

MeasureTime frame
Asymptomatic lymphocele at the time of discharge; Asymptomatic lymphocele within 6 months after surgical treatment; Rehospitalization rate within 6 months after surgical treatment; Quality of Life (QLQ-C30, EORTC)

Countries

Germany

Contacts

Public ContactSimone Zendler

Studienzentrale der Klinik für Urologie

simone.zendler@medma.uni-heidelberg.de0621/383-4973

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 23, 2026