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Endoscopic vs. conventional radical iliacal lympadenectomy for malignant melanoma - a randomized controlled trial

Not Applicable
Recruiting
Conditions
C43
Intrapelvic lymph nodes
C77.5
Malignant 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
NameTimeMethod
evel of pain at first postoperative day measured with a visual analoge scale
Secondary Outcome Measures
NameTimeMethod
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
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