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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Control Trial for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection

Conditions
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Lymph Node Dissection, Lymphoedema, Lymphocoele

Intervention / Treatment
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* Device: Harmonic scalpel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Monocentric, open, interventional, randomized with two arms 1:1
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Harmonic<br>Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH) | Device: Harmonic scalpel<br> <br> |
| Active Comparator: Control<br>Monopolar scalpel and ligature | Device: Harmonic scalpel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Draining Time | Duration (days) between surgery and removal of postoperative suction drain | Lymph quantity measured every day. Drained removed when < 50 ml. per day for 2 consecutive days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Amount of Drained Lymph | Patients had to record on a list the amount in ml. of lymph in the suction drain bottles | Lymph quantity measured every day, up to 50 days. |