Does LigaSure reduce fluid drainage in axillary dissection? A randomized prospective clinical trial

Abstract

Background: Axillary lymph node dissection (ALND) is an integral part of breast cancer treatment. It is required in about 40-50% of patients. The placement of a drain in the axilla after an operation is current surgical practice. Short surgical stay programmes increase operating efficiency and reduce medical care costs, without compromising quality of care. LigaSure(™) is a new haemostatic device that uses bipolar energy to seal vessels. The aim of this study is to determine whether axillary dissection with LigaSure(™) reduces the time of wound drainage, the duration of surgical intervention and the volume of drainage after treatment.

Patients and methods: This study is a prospective randomized controlled trial. A total of 100 women with breast cancer who needed axillary dissection were randomized into the LigaSure(™) or conventional axillary dissection group. Levels I to III lymph node dissection was performed. A closed suction drain was always placed in the axilla and removed after 6-8 days or when fluid amount was <60 cc in the previous 24 hours.

Results: THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE TWO GROUPS WHEN CONSIDERING THE DURATION OF SURGICAL PROCEDURE: average duration was 70.7 ± 24.66 minutes for LigaSure(™) patients, while in the conventional dissection group the mean was 70.6 ± 22.47 minutes (p=0.98). Total amount of drained fluid was 624.49 cc in the LigaSure(™) axillary dissection group and 792.96 in the conventional ALND group; this difference did not achieve statistical significance (p=0.09); the duration of draining was also similar, with no statistical difference (p=0.15).

Conclusions: The present study did not show clear advantages in LigaSure(™) use for ALND, although it represents a good haemostatic device, especially in abdominal surgery.

Keywords: Breast carcinoma; LigaSure; axillary dissection; breast cancer surgery; drain; haemostasis; seroma.