Endoscopic vs. conventional radical inguinal lympadenectomy for malignant melanoma - a randomized controled trial

Not Applicable

Recruiting

• Conditions: C43; C77.4; Malignant melanoma of skin; Inguinal and lower limb lymph nodes

• Registration Number: DRKS00006229
• Lead Sponsor: niversitätsmedizin Berlin - Charité Campus MitteKlinik für Allgemein-, Visceral-, Gefäß- und Thoraxchirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

histologically proven inguinal lymph node metastases of an malignant melanoma (biopsy or FNAC)

Exclusion Criteria

local macrometastases >25mm diameter, previous inguinal lymph node excisions (beside sentinel node excision), previous local radiation, preexisting lymphedema, impossibility of a complete 30-days-follow-up, pregnancy, coagulation disorders

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of wound healing disorders (wound infections acc. CTC-criteria, dehiscence, edge necrosis >1cm, every reason for revisional operation) within 30 days after operation

Secondary Outcome Measures

Name	Time	Method
incidence of local and general complications within 30 days, number of harvested lymph nodes, incidence of local tumor recurrence within 12 months, incidence and endurance of postoperative lymphatic fistulas, postoperative pain scores (visual analog scale) within 7 days, quality of life (short form-36 questionnaire) 3, 7, 30 days and 1 year after surgery, time for surgery, treatment costs, time of hospitalization