The journal of obstetrics and gynaecology research · 2022
Clinical feasibility of absorbable gelatin film adhesion barrier (GM142 "TENALEAF®") in gynecological laparoscopic surgery: Safety assessment for first-in-human use and surgical video.
Многоцентровое исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Kikuchi Iwaho, Momoeda Mikio, Ujihira Takafumi, Iguchi Michiyo, Koga Kaori, Morita Mineto
Аннотация
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.
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.