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.
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Parallel
single-channel uterine fibroid morcellation system
DeviceConventional laparoscopic myomectomy is performed with the use of a single-channel uterine fibroid morcellation system for fragmentation and retrieval of the fibroids during the procedure.
Multi-channel specimen retrieval bag + conventional laparoscopic uterine fibroid morcellator
DeviceIn conventional laparoscopic myomectomy, a multi-channel specimen retrieval bag is used during the procedure, along with a conventional laparoscopic uterine fibroid morcellator for fragmentation and retrieval of the fibroids.
Time required for fibroid fragmentation and retrieval
Using a stopwatch, record the time it takes from the placement of the single-channel uterine fibroid morcellation system or the multi-channel specimen retrieval bag until the complete removal of the single-channel uterine fibroid morcellation system or the multi-channel specimen retrieval bag from the abdominal cavity.
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