The goal of this observational study is to evaluate the feasibility, safety, and effectiveness of a fully enclosed protective device system in laparoscopic myomectomy to achieve tumor-free protection throughout the entire surgical procedure in women aged 28-46 years diagnosed with uterine fibroids who require laparoscopic myomectomy. The main questions it aims to answer are: Can the fully enclosed protective device system successfully achieve complete physical isolation of fibroid tissue during laparoscopic myomectomy and morcellation? Does the use of this device reduce the risk of tissue dissemination or leakage while maintaining acceptable surgical outcomes such as operative time, blood loss, and postoperative recovery? Participants will undergo laparoscopic myomectomy assisted by the fully enclosed protective device system. During the procedure, participants will: undergo laparoscopic removal of uterine fibroids using a fully enclosed protective isolation system have the fibroid dissected and contained within a protective bag during the entire procedure receive in-bag morcellation or fragmentation of fibroid tissue within a sealed environment be evaluated for operative outcomes including fibroid size, operative time, intraoperative blood loss, integrity of the protective bag, and postoperative hospital stay
Study Type
OBSERVATIONAL
Enrollment
20
China-Japan Friendship Hospital
Beijing, No. 2, Xinghua East Street, Chaoyang District, China
Bag integrity and absence of tissue leakage
Assessment of whether the protective bag remains intact without rupture or leakage during the procedure.
Time frame: Intraoperative and immediately after surgery
Operative time
Total duration of the surgical procedure
Time frame: During surgery
Intraoperative blood loss
Estimated blood loss measured in milliliters
Time frame: During surgery
Fibroid size
Maximum diameter of the removed uterine fibroid measured intraoperatively and confirmed by postoperative pathology
Time frame: Immediately after surgical removal and confirmed by pathology
Postoperative hospital stay
Length of postoperative hospital stay measured in days
Time frame: Perioperatively (from surgery up to hospital discharge, within 7 days)
Postoperative complications
Incidence of postoperative complications such as infection, fever, or pelvic inflammation
Time frame: From the day of surgery through 30 days postoperatively
Histopathological diagnosis
Confirmation of the pathological type of removed fibroids by postoperative pathology
Time frame: Immediately after surgical removal, confirmed by postoperative pathology
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