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

Lausanne University Hospital (CHUV)

Status

Completed

Conditions

Lymph Node Dissection

Lymphocoele

Lymphoedema

Treatments

Device: Harmonic scalpel

Study type

Interventional

Funder types

Other

Identifiers

NCT02476357

LYMPH-01

Details and patient eligibility

About

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.

Full description

The aim of the present study was to assess the value of USS in RLND in groin and axilla in a homogenous group of patients.

In a tertiary academic centre, patients undergoing groin or axillary RLND or CLND after positive SLNB for melanoma, skin cancer, sarcoma or breast cancer were enrolled in a randomized controlled trial for surgical dissection technique. The study was reviewed and accepted by the local ethical committee. Patients were older than 18 years and gave an informed consent. All patients with a past medical history of contralateral lymph node dissection or other cause of lymphedema (previous trauma, deep venous thrombosis, radiotherapy, etc.) were excluded. Patients undergoing both iliac and inguinal lymph node dissections were excluded as well. No patients had distant or in transit metastasis. Patients were randomly assigned using sealed numbered envelopes to one of two arms of the study in a 1: 1 ratio. In the first group the dissection was conducted with USS (Harmonic Focus ®, Ethicon Endo-Surgery (Europe) GmbH) exclusively. In the control group the lymphadenectomy was performed using ligation and monopolar electrocautery. All patients were operated by a dedicated team headed by a single surgeon.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.