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

Not Applicable

Completed

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.

Detailed 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Control	Harmonic scalpel	Monopolar scalpel and ligature
Harmonic	Harmonic scalpel	Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH)

Primary Outcome Measures

Name	Time	Method
Postoperative Draining Time	Lymph quantity measured every day. Drained removed when < 50 ml. per day for 2 consecutive days	Duration (days) between surgery and removal of postoperative suction drain

Secondary Outcome Measures

Name	Time	Method
Daily Amount of Drained Lymph	Lymph quantity measured every day, up to 50 days.	Patients had to record on a list the amount in ml. of lymph in the suction drain bottles