Trial document




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  DRKS00006264

Trial Description

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Title

Endoscopic vs. conventional radical iliacal lympadenectomy for malignant melanoma - a randomized controlled 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 not only the complete resection of the inguinal basin. Additionally the iliacal lymph nodes should be resectetd. Therefore an additional abdominal incision is inevitable. This trial should investigate, wheather an endoscopic operation technique can decreas the levels of postoperative pain.

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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 (AJCC stage III). Additionally a radical iliacal resection should be performed. This extension is afflicted with a relevant morbidity. Generally, minimally invasive laparoscopic surgery has proven its ability to decrease postoperative pain levels. However, there are no data of randomized controled trials on the influence of laparoscopic technique on the postoperative pain after iliacal lymph node dissection for melanoma.

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Organizational Data

  •   DRKS00006264
  •   2014/06/27
  •   [---]*
  •   yes
  •   Approved
  •   EA1/135/14, 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
  •   C77.5 -  Secondary and unspecified malignant neoplasm: Intrapelvic lymph nodes
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Interventions/Observational Groups

  •   conventional radical iliacal lymph node dissection
  •   laparoscopic radical iliacal lymph node dissection
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Characteristics

  •   Interventional
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  •   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

Level of pain at first postoperative day measured with a visual analoge scale

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/09/05
  •   40
  •   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

previous iliacal surgery or radiation, pregnancy, macrometastases >25mm diameter, impossibility of a complete 30-days-follow-up,
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.