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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00006229

Enrollment

108

Registered

2014-06-17

Start date

2014-08-29

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

C43 C77.4

Interventions

Group 1: conventional radical inguinal lymph node dissection Group 2: endoscopic radical inguinal lymph node dissection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactWieland Raue

Universitätsmedizin Berlin - Charité Campus MitteKlinik für Allgemein-, Visceral-, Gefäß- und Thoraxchirurgie

wieland.raue@charite.de+4930450522048

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026