Evaluation of local hemostatic effect of microporous polysaccharide hemospheres products in thyroid surgery: a prospective randomized controlled study
Enver Kunduz1, Erhan Aysan1, Ufuk Oğuz İdiz2, Yeliz Emine Ersoy1, Hüseyin Kazım Bektaşoğlu1, Samet Yığman1, Hacer Kundakcıoğlu1
1Department of General Surgery, Bezmialem Vakif University School of Medicine, Istanbul, Turkey
2Clinic of General Surgery, Istanbul Training and Research Hospital, Istanbul, Turkey
Abstract
Objective: Bleeding is a rare and dangerous complication of thyroid surgery. One of the hemostatic agents used during surgery are microporous polysaccharide hemospheres (MPH) which are local hemostatic agents acquired from purified potato starch. The aim of this study was to evaluate the efficiency of two MPH, produced with different biotechniques, in decreasing hemorrhages and drainage following thyroidectomy.
Material and Methods: A statistical power analysis predicted that totally 20 patients per each group was needed within 95% confidential interval. Patients were randomized into 3 groups as control, Haemocer TM and Arista TM to be 20 patients in each group. Following bilateral total thyroidectomy, no additional procedures were performed in the first group, 5 g Haemocer was administered to the second group, 5 g Arista was administered to the third group into the operational field, and the operation was ended by placing a double-sided hemovac drain. At post-operative day one, drainage amount, calcium (Ca), phosphate (P) and parathyroid hormone (PTH) levels were noted.
Results: No significant difference was noted between the groups for age, gender, removed tissue weight and malignant pathology rates. Also, no significant difference was noted between post-operative drainages and Ca, P, PTH levels of groups either. Hoarseness or hematoma were not observed in any patient.
Conclusion: MPHs are not proven in effectiveness in decreasing post-operative hemorrhages, which might be a key to avoiding unnecessary expenses.
Keywords: Microporous, polysaccharide, hemospheres, thyroid, hemostasis
Cite this article as: Kunduz E, Aysan E, İdiz UO, Ersoy YE, Bektaşoğlu HK, Yığman S, et al. Evaluation of local hemostatic effect of microporous polysaccharide hemospheres products in thyroid surgery: a prospective randomized controlled study. Turk J Surg 2019; 35 (1): 49-53
Ethics committee approval was received for this study from the Ethics Committee of Bezmialem Vakıf University (2013/439).
Written informed consent was obtained from patient who participated in this study.
Externally peer-reviewed.
Consept - E.A., E.K.; Design - E.K., E.A.; Supervision - E.A., Y.E.E.; Resource - E.K., O.İ.; Materials - O.İ.; Data Collection and/or Processing - Y.E.E.; H.K.B.; Analysis and Interpretation - E.K., S.Y.; Literature Search - E.K., S.Y., H.K.; Writing Manuscript - E.K., O.İ.; Critical Reviews - E.K, E.A.
The authors have no conflicts of interest to declare.
The authors declared that this study has received no financial support.