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

Phase 3

• Conditions: C61; I89.8; Malignant neoplasm of prostate; Other specified noninfective disorders of lymphatic vessels and lymph nodes

• Registration Number: DRKS00016794
• Lead Sponsor: niversitätsklinikum Mannheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-13
• Study Completion: 2022-08-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 551

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Asymptomatic lymphocele at the time of discharge;<br>Asymptomatic lymphocele within 6 months after surgical treatment;<br>Rehospitalization rate within 6 months after surgical treatment;<br>Quality of Life (QLQ-C30, EORTC)