Single-channel Fibroid Morcellation System Used in Clinical Research on Laparoscopic Myomectomy

This prospective, single-center, randomized, single-blind controlled trial aims to evaluate the efficacy and safety of a novel single-channel retrieval bag compared to a widely used dual-channel retrieval bag in laparoscopic myomectomy. A total of 78 patients aged 18 to 45 years with uterine fibroids (diameter ≥ 4 cm and requiring preservation of the uterus) will be randomly assigned to the experimental group and the control group in a 1:1 ratio. The experimental group will use the single-channel system (an upgraded high-transparency large-capacity retrieval bag + fragmentation device with a fibroid limiter), while the control group will utilize a standard dual-channel bag + fragmentation device with a fibroid limiter. The primary outcome measure will be the total surgical time. Secondary outcome measures will include the success rate of placement, intraoperative leakage rate, surgeon's learning curve, and intraoperative/postoperative complications. Patients will be followed up at 3 months, 6 months, 12 months, and 24 months to assess recurrence and the risk of fibroid dissemination. Preliminary data (n = 22) indicate that the single-channel myomectomy fragmentation system significantly reduced total sampling time (15.4 minutes vs. 36.7 minutes, p = 0.005) while demonstrating comparable safety. This study utilizes the same electric fragmentation device for both the experimental and control groups, with the experimental group employing a further upgraded single-channel retrieval bag to verify the advantages of the novel single-channel retrieval bag in simplifying surgical procedures, improving efficiency, and providing a smoother learning curve, thereby offering evidence for its clinical promotion and patent conversion, particularly suitable for primary care hospitals.

Sex

Female

Minimum age

18 Years

Maximum age

45 Years

Inclusion Criteria:

1. Patients with uterine fibroids who meet the surgical criteria.
2. Aged 18 and above but below 45, those who firmly request to retain the uterus.
3. Patients planning to undergo laparoscopic removal of uterine fibroids.
4. Those who understand the purpose, procedures, possible risks of this trial, voluntarily participate in this study, and sign the informed consent form.

Exclusion Criteria:

1. Patients whose overall condition cannot tolerate laparoscopic surgery.
2. Patients who require surgeries other than laparoscopic fibroid removal surgery (excluding pelvic adhesion release, excision of mesosalpinx cysts less than 2cm, and excision/electrocoagulation of superficial intraperitoneal lesions).
3. Considering the possibility of malignant transformation of uterine fibroids preoperatively.
4. Preoperative diagnosis is unclear and needs to be differentiated from ovarian tumors.
5. History of previous lower abdominal surgery or severe pelvic or abdominal adhesions.
6. Presence of untreated infectious sexual diseases, including but not limited to vaginitis, cervicitis, and pelvic inflammatory disease.