Abstract
Background: The Vagi-Pipe® is a useful device for performing total laparoscopic hysterectomy. The conventional model of the Vagi-Pipe® is unable to grasp the uterus during colpotomy for recovery of the resected uterus. However, the modified C-Type Vagi-Pipe® model has a shape that allows insertion into the vagina without removing the uterus manipulator. This study aimed to prospectively investigate the safety and efficacy of the C-Type Vagi-Pipe® in total laparoscopic hysterectomies. Methods: A total of 25 female subjects between 20 and 60 years old with uterine fibroids or adenomyosis will be included in this study. Patients with complications considered unsuitable for this study by the investigators will be excluded. The C-Type Vagi-Pipe® will be used rather than the conventional Vagi-Pipe® when performing total laparoscopic hysterectomy. The primary outcome will be safety, and the secondary endpoints will be operation time, bleeding volume, and presence of complications. The protocol was approved by the institutional review board of Kyoto Prefectural University of Medicine. In accordance with the Declaration of Helsinki, written informed consent will be obtained from all patients before registration. Discussion: This study seeks to confirm the safety and effectiveness of the C-Type Vagi-Pipe® for total laparoscopic hysterectomy. Once confirmed, the introduction of the C-Type Vagi-Pipe® is expected to make the total laparoscopic hysterectomy procedure easier to perform and thereby allow it to be performed in many more medical facilities. Results of the study will be disseminated via publications in peer-reviewed journals. Trial registration: Japan Registry of Clinical Trials (jRCT), jRCTs052180221. Registered 18 March 2019 - Retrospectively registered, https://jrct.niph.go.jp/search
41: Total laparoscopic hysterectomy for uterine didelphys with large uterine fibroids