Clinical Research on the Application of Single-channel Uterine Fibroid Morcellation System in Laparoscopic Myomectomy

Research Purpose The purpose of this study is to explore whether the application of a single-channel uterine fibroid morcellation system compared to a multi-channel specimen retrieval bag during laparoscopic myomectomy can shorten the operative time and improve the efficiency of fibroid removal. Research Design This study is a single-center, randomized, single-blind, 1:1 controlled trial. Intervention Measures Study participants were randomly assigned in a 1:1 ratio into two groups. Experimental group: Conventional laparoscopic myomectomy with the use of a single-channel uterine fibroid morcellation system for fragmentation and retrieval of the fibroids. Control group: Conventional laparoscopic myomectomy with the use of a multi-channel specimen retrieval bag and a conventional laparoscopic uterine fibroid morcellator for fragmentation and retrieval of the fibroids. Observation Indicators Primary observation indicator: Time required for fibroid fragmentation and retrieval (from the placement of the single-channel uterine fibroid morcellation system or the multi-channel specimen retrieval bag to complete removal from the abdominal cavity). Secondary observation indicators: Success rate of placement, intraoperative damage and leakage rate, gynecological surgeon satisfaction with the surgery, total weight of retrieved uterine fibroid fragments.

NCT Number	NCT06442605
Lead Sponsor	First People's Hospital of Hangzhou
Conditions	Leiomyoma, Uterine
Enrollment	22 participants
Start Date	2024-06-20
Primary Completion	2025-06-19 (estimated)
Study Completion	2027-06-19 (estimated)
Updated on ClinicalTrials.gov	2024-06-04