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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00006264

Enrollment

Registered

2014-06-27

Start date

2014-09-05

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 C77.5

Interventions

Group 1: conventional radical iliacal lymph node dissection Group 2: laparoscopic radical iliacal 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: previous iliacal surgery or radiation, pregnancy, macrometastases >25mm diameter, impossibility of a complete 30-days-follow-up, coagulation disorders

Design outcomes

Primary

Measure	Time frame
Level of pain at first postoperative day measured with a visual analoge scale	—

Secondary

Measure	Time frame
Level 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	—

Measure

Time frame

Level 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

—

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