Trial document




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  DRKS00006229

Trial Description

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Title

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

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Recent guidelines for treatment of malignant melanoma with inguinal lymph node metastases advise a complete resection of that lymph node basin. Usually an incision of approximately 10cm is necessary. Unfortunately patients develop postoperatively a prolonged wound healing or even wound infection in up to 50%. This trial should investigate, wheather a endoscopic operation technique can prevent from wound healing disturbances.

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Brief Summary in Scientific Language

Following the german and the NCCN guidelines for treatment of malignant melanoma a radical inguinal lymph node dissection is recommended in cases with proven inguinal lymph node metastases (stage III). The postoperative morbidity is high. Wound infections and prolonged wound healing is frequent with an incidence of up to 50%. A relevant decrease of this incidence after using endoscopic techniques is reported in several non-randomized trials. There are no data of randomized controled trials.

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Organizational Data

  •   DRKS00006229
  •   2014/06/17
  •   [---]*
  •   yes
  •   Approved
  •   EA1/136/14, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C43 -  Malignant melanoma of skin
  •   C77.4 -  Secondary and unspecified malignant neoplasm: Inguinal and lower limb lymph nodes
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Interventions/Observational Groups

  •   conventional radical inguinal lymph node dissection
  •   endoscopic radical inguinal lymph node dissection
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/08/29
  •   108
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

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

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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

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Addresses

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    • Universitätsmedizin Berlin - Charité Campus MitteKlinik für Allgemein-, Visceral-, Gefäß- und Thoraxchirurgie
    • Mr.  PD Dr. med.  Wieland  Raue 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Universitätsmedizin Berlin - Charité Campus MitteKlinik für Allgemein-, Visceral-, Gefäß- und Thoraxchirurgie
    • Mr.  PD Dr. med.  Wieland  Raue 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Universitätsmedizin Berlin - Charité Campus MitteKlinik für Allgemein-, Visceral-, Gefäß- und Thoraxchirurgie
    • Mr.  PD Dr. med.  Wieland  Raue 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin Berlin - Charité Campus MitteKlinik für Allgemein-, Visceral-, Gefäß- und Thoraxchirurgie
    • Mr.  PD Dr. med.  Wieland  Raue 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.