Uterine Fibroids (Leiomyoma)
Conditions
Brief summary
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
Interventions
None listed
Sponsors
China-Japan Friendship Hospital
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
28 Years to 46 Years
Healthy volunteers
No
Inclusion criteria
Female patients aged 28 to 46 years Diagnosis of uterine fibroids confirmed by pelvic ultrasound and magnetic resonance imaging (MRI) Maximum diameter of the dominant fibroid between 6 and 10 cm Scheduled to undergo laparoscopic myomectomy Preoperative evaluation consistent with benign uterine fibroids Able and willing to provide written informed consent
Exclusion criteria
Suspicion of uterine malignancy based on imaging findings or clinical assessment Presence of severe systemic disease contraindicating laparoscopic surgery Current pregnancy Inability or unwillingness to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bag integrity and absence of tissue leakage | Intraoperative and immediately after surgery | Assessment of whether the protective bag remains intact without rupture or leakage during the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | During surgery | Total duration of the surgical procedure |
| Intraoperative blood loss | During surgery | Estimated blood loss measured in milliliters |
| Fibroid size | Immediately after surgical removal and confirmed by pathology | Maximum diameter of the removed uterine fibroid measured intraoperatively and confirmed by postoperative pathology |
| Postoperative hospital stay | Perioperatively (from surgery up to hospital discharge, within 7 days) | Length of postoperative hospital stay measured in days |
| Postoperative complications | From the day of surgery through 30 days postoperatively | Incidence of postoperative complications such as infection, fever, or pelvic inflammation |
| Histopathological diagnosis | Immediately after surgical removal, confirmed by postoperative pathology | Confirmation of the pathological type of removed fibroids by postoperative pathology |
Countries
China
Outcome results
None listed