Clinical feasibility of absorbable gelatin film adhesion barrier (GM142 "TENALEAF®") in gynecological laparoscopic surgery: Safety assessment for first-in-human use and surgical video.
adhesion barrier
gelatin film
laparoscopic surgery
myomectomy
total laparoscopic hysterectomy
Journal
The journal of obstetrics and gynaecology research
ISSN: 1447-0756
Titre abrégé: J Obstet Gynaecol Res
Pays: Australia
ID NLM: 9612761
Informations de publication
Date de publication:
Mar 2023
Mar 2023
Historique:
received:
15
05
2022
accepted:
07
12
2022
pubmed:
29
12
2022
medline:
8
3
2023
entrez:
28
12
2022
Statut:
ppublish
Résumé
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. This multicenter open study enrolled 34 patients from November 2018 to October 2019. 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. This study showed the safety and clinical feasibility GM142 as an adhesion barrier.
Substances chimiques
gelatin film
0
Types de publication
Multicenter Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
980-987Informations de copyright
© 2022 Japan Society of Obstetrics and Gynecology.
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