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A Study for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection

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ClinicalTrials.gov Identifier: NCT02476357
Recruitment Status : Completed
First Posted : June 19, 2015
Last Update Posted : June 19, 2015
Sponsor:
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals

Brief Summary:
Patients undergoing groin or axillary Radical lymph node dissection (RLND) or completion lymph node dissection (CLND, after positive sentinel lymph node biopsy (SLNB) for melanoma or breast cancer were randomized in a controlled trial for surgical dissection technique. Harmonic scalpel dissection were compared with classic dissection in term of lymphocoele and oedema.

Condition or disease Intervention/treatment Phase
Lymph Node Dissection Lymphoedema Lymphocoele Device: Harmonic scalpel Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Randomized Control Trial for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection
Study Start Date : January 2009
Actual Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Harmonic
Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH)
Device: Harmonic scalpel
Active Comparator: Control
Monopolar scalpel and ligature
Device: Harmonic scalpel



Primary Outcome Measures :
  1. Post operative draining time [ Time Frame: 45 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adult patients undergoing groin or axillary Radical lymph node dissection (RLND) or completion lymph node dissection (CLND), after positive sentinel lymph node biopsy (SLNB) for melanoma or breast cancer were included.

Exclusion Criteria:

  • Patient with a past medical history of contralateral lymph node dissection or other cause for lymphedema (trauma, deep venous thrombosis, radiotherapy, etc.) were excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476357


Locations
Switzerland
Department of Visceral Surgery, University Hospital Center
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne Hospitals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nicolas DEMARTINES, Professor, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT02476357     History of Changes
Other Study ID Numbers: LYMPH-01
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: June 19, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Lymphedema
Lymphocele
Lymphatic Diseases
Cysts
Neoplasms