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Clinical research on the application of single-channel uterine fibroid morcellation system in laparoscopic myomectomy.

Clinical research on the application of single-channel uterine fibroid morcellation system in laparoscopic myomectomy.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085851
Enrollment
Unknown
Registered
2024-06-19
Start date
2024-06-20
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine fibroids

Interventions

Control group:Multi-channel specimen retrieval bag + conventional laparoscopic uterine fibroid morcellator
Experimental group:Single-port myomectomy system

Sponsors

Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Patients with uterine fibroids who meet the surgical indications. Patients aged 18 and above but below 45, who strongly request to preserve the uterus. Patients planning to undergo laparoscopic myomectomy. Those who understand the purpose, procedures, potential risks of this trial, voluntarily participate in this study, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Patients who cannot tolerate laparoscopic surgery due to their overall physical condition. Patients with multiple fibroids have at least 4 fibroids, with the largest diameter of a single fibroid being equal to or greater than 10cm. Patients who require surgical procedures other than laparoscopic myomectomy (excluding pelvic adhesion lysis, resection of mesosalpingeal cysts measuring less than 2cm, and superficial intraperitoneal lesions resection/electrocoagulation). Preoperatively considering the possibility of uterine fibroid malignancy. Patients with preoperative unclear diagnosis, requiring differentiation from ovarian tumors. Previously undergone lower abdominal or pelvic intraperitoneal surgery, or patients with severe pelvic or abdominal adhesions. Presence of untreated infectious sexual diseases, including but not limited to vaginitis, cervical inflammatory diseases, and pelvic inflammatory diseases. Patients who cannot understand the research protocol, cannot cooperate with the research and follow-up, and any other patients that researchers deem unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Myoma crushing and extraction time;

Secondary

MeasureTime frame
Placement success rate;Intraoperative damage and leakage rate;

Countries

China

Contacts

Public ContactJinyi Tong

Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University

362303714@qq.com+86 135 8881 8180

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026