The Efficacy and Safety of Guardix-SG® in Patients Who Are Undergoing Thyroid Surgery: A Randomized, Prospective, Double-blinded Study / 대한내분비외과학회지

ABSTRACT

PURPOSE: Postoperative adhesion of the surgical field seems to be troublesome not only to the patients, but also to the surgeons. Guardix-SG® is a poloxamer/alginate mixture that reduced the incidence of postoperative adhesions when it is added to the abdominal surgery in animal models and also in clinical trials. This study was a randomized, prospective, double-blinded study to evaluate the antiadhesive efficacy and safety of Guardix-SG® after total thyroidectomy. METHODS: A total of 89 patients who underwent total thyroidectomy between July 2008 and February 2009 in Severance Hospital and Gang-Nam Severance Hospital were randomized to either the Guardix-SG® treatment group (n=45) or the non-treatmentcontrol group (n=44). The patients were asked about their clinical symptoms (hypesthesia or paresthesia on the operative site (SN) and swallowing discomfort (SW)) by using a questionnaire, and the swallowing function was evaluated using Marshmallow Esophagography by one physician. The clinical symptoms and Marshmallow Esophagography were scored according to the results of assessment. The most severe state was scored as 0 and normal was scored as 3. RESULTS: The scores of the clinical symptoms (SN and SW) were 2.67 and 2.49 in the treatment group, and 2.09 and 1.80 in the control group, respectively, at the postoperative 6th week (P=0.001, <0.001). The scores of the Marshmallow Esophagography were 2.93 in the treatment group and 2.73 in the control group (P=0.033). Abnormal findings were seen in 2 patients (4.4%) in the treatment group and in 10 patients (22.7%) in the control group (P=0.014). CONCLUSION: Guardix-SG® seems to be effective in preventing adhesion after thyroidectomy. Further studies involving a larger number of subjects will be needed to make an application guideline.