Effect of a Polyglycolic Acid Mesh Sheet (Neoveil™) in Thyroid Cancer Surgery: A Prospective Randomized Controlled Trial

Abstract

Papillary thyroid cancer (PTC) is the most common type of thyroid cancer. Surgery for PTC involves resection of the thyroid gland and central lymph node dissection. Central lymph node dissection is associated with an increased amount of fluid from the dissection area and chyle leakage due to thoracic duct injury. There are few studies that deal with reducing fluid drainage and preventing chyle leakage after thyroid surgery with central lymph node dissection. A polyglycolic acid mesh sheet (Neoveil™) has been demonstrated to prevent postoperative fluid leakage in other surgeries. This study aims to evaluate whether a polyglycolic acid mesh sheet can reduce postoperative drainage and chyle leakage in papillary thyroid cancer surgery, and this study was designed as a prospective, open-label, randomized controlled trial in a single university hospital. The patients were randomly assigned to having only fibrin glue used in the central node dissection area (control group) or to having a polyglycolic acid mesh sheet applied after fibrin glue (treatment group). A total of 330 patients were enrolled, of which 5 patients were excluded. A total of 161 patients were included in the treatment group, and 164 patients were included in the control group. The primary outcome was the drainage amount from the Jackson-Pratt drain, and the secondary outcome was the triglyceride level in the drained fluid on the 1st and 2nd postoperative days. The drainage amount was significantly lower in the treatment group on the 2nd postoperative day (60.9 ± 34.9 mL vs. 72.3 ± 38.0 mL, p = 0.005). The sum of drainage amount during the whole postoperative days (1st and 2nd days) was also significantly lower in the treatment group (142.7 ± 71.0 mL vs. 162.5 ± 71.5 mL, p = 0.013). The postoperative triglyceride levels were lower in the treatment group but were not statistically significant (92.1 ± 60.1 mg/dL vs. 81.3 ± 58.7 mg/dL on postoperative day 1, p = 0.104 and 67.6 ± 99.2 mg/dL vs. 53.6 ± 80.4 mg/dL on postoperative day 2, p = 0.162). No adverse effects were observed in the treatment groups during the postoperative 9-month follow-up. Our study suggests that polyglycolic acid mesh sheets can be safely applied to reduce postoperative drainage amount in thyroidectomy patients who need lymph node dissection.