Prospective Randomized Study to Compare Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Therapeutic Lymph Node Dissection With or Without the Use of an Ultrasonic Scalpel.

BACKGROUND: Many attempts to prevent lymphatic complications following therapeutic lymph node dissection (TLND) have included modifications in surgical techniques through the use of ultrasonic scalpels (USS) or lymphostatic agents. Previous randomized studies that enrolled heterogeneous groups of patients attempted to confirm the efficacy of such techniques. The aim of the present study was to evaluate the efficacy of the USS following TLND. METHODS: Between 2009 and 2013, patients undergoing inguinal or axillary TLND or completion lymph node dissection after positive sentinel lymph node biopsy for melanoma, squamous cell carcinoma or sarcoma were randomized into two surgical dissection technique groups. In the USS dissection arm, surgery was conducted using a USS. These were compared with a control group whereby ligation and monopolar electrocautery was utilized. For axillary dissection, a standardized level III lymphadenectomy was performed. A complete inguinal lymphadenectomy including Cloquet's node was performed, and at the end of the procedure a Redon suction drain was routinely placed in the axilla and groin. The primary endpoint was to compare the time to drain removal in both groups, while the secondary endpoint was to evaluate the rate of complications (infection, fistula, lymphocele formation, wound dehiscence, lymphedema) between the two groups. RESULTS: A total of 80 patients were enrolled in this trial; 40 patients were randomly assigned to both the USS group and the control (C) group. No significant differences were observed in terms of duration of drainage (USS: 31 ± 20 vs. C: 32 ± 18; p = 0.83); however, a significantly increased rate of lymphedema (defined as an increased circumference of the operated limb of more than 10 %) was identified in the USS group (USS: 50 % vs. C: 27.5 %; p = 0.04). No other significant differences were recorded for postoperative complications, including surgical site infection (USS: 5 % vs. C: 7.5 %; p = 0.68), lymphatic fistula (USS: 5 % vs. C: 2.5 %; p = 0.62), lymphocele (USS: 32.5 % vs. C: 22.5 %; p = 0.33), and hematoma (USS: 5 % vs. C: 2.5 %; p = 0.62). CONCLUSION: The use of USS failed to offer any significant reduction in length of drain usage and operative complication, but it seems to increase the rate of lymphedema formation