Clinical feasibility of absorbable gelatin film adhesion barrier (GM142 "TENALEAF®") in gynecological laparoscopic surgery: Safety assessment for first-in-human use and surgical video

Abstract

Aim: To evaluate the safety and operability of the GM142 (TENALEAF®, Medical Division, Gunze Limited, Tokyo, Japan) adhesion barrier applied in patients undergoing surgery for benign gynecologic disease.

Methods: This multicenter open study enrolled 34 patients from November 2018 to October 2019.

Results: The primary outcome was the incidence of adverse events (AE) within 12 weeks postoperatively. None of the 30 patients completing the study experienced a life-threatening AE. Thirteen patients (43.3%) suffered 30 mild or moderate AE in total. No intestinal obstruction (0/30) was observed, with the sample size justified by the AdSpray® trial (8/61 patients with AE). No gelatin-specific Immunoglobulin E (IgE) antibodies were induced in the patients. The adhesion barrier could be easily inserted (even via trocar) and positioned. After malfunctions were reported in six patients, the instructions for use were updated for trocar use.

Conclusion: This study showed the safety and clinical feasibility GM142 as an adhesion barrier.

Keywords: adhesion barrier; gelatin film; laparoscopic surgery; myomectomy; total laparoscopic hysterectomy.