Single-channel Fibroid Morcellation System Used in Clinical Research on Laparoscopic Myomectomy
Starting soon · Not applicable
Conditions studied: Uterine Fibroids
In brief
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.
Key facts
- Study ID
- NCT07512973
- Run by
- First People's Hospital of Hangzhou
- People needed
- 78
- Starts
- 2026-05-01
- Expected to finish
- 2029-05-01
- Last updated by the study team
- 2026-04-06
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Patients with uterine fibroids who meet the surgical criteria.
- Aged 18 and above but below 45, those who firmly request to retain the uterus.
- Patients planning to undergo laparoscopic removal of uterine fibroids.
- Those who understand the purpose, procedures, possible risks of this trial, voluntarily participate in this study, and sign the informed consent form.
You may not qualify if…
- Patients whose overall condition cannot tolerate laparoscopic surgery.
- 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).
- Considering the possibility of malignant transformation of uterine fibroids preoperatively.
- Preoperative diagnosis is unclear and needs to be differentiated from ovarian tumors.
- History of previous lower abdominal surgery or severe pelvic or abdominal adhesions.
- Presence of untreated infectious sexual diseases, including but not limited to vaginitis, cervicitis, and pelvic inflammatory disease.
Full record on ClinicalTrials.gov
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