Endoscopic vs. conventional radical iliacal lympadenectomy for malignant melanoma - a randomized controlled trial
Not Applicable
Recruiting
- Conditions
- C43Intrapelvic lymph nodesC77.5Malignant melanoma of skin
- Registration Number
- DRKS00006264
- Lead Sponsor
- niversitätsmedizin Berlin - Charité Campus MitteKlinik für Allgemein-, Visceral-, Gefäß- und Thoraxchirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
histologically proven inguinal lymph node metastases of an malignant melanoma (biopsy or FNAC)
Exclusion Criteria
previous iliacal surgery or radiation, pregnancy, macrometastases >25mm diameter, impossibility of a complete 30-days-follow-up,
coagulation disorders
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method evel of pain at first postoperative day measured with a visual analoge scale
- Secondary Outcome Measures
Name Time Method evel of pain at postoperative days 2 til 7 measured with a visual analoge scale, postoperative quality of life at postoperative days 3+7+30 an 12 months after surgery measured with the SF-36 questionnaire, incidence of postoperative wound healing disorders, incidence of local and general complications, incidence and endurrance of postoperative lymphatic fistulas, number of harvested lymph nodes, incidence of local recurrence within one year after surgery