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A Study on the Safety and Efficacy of Laparoscopic Specialized Myomectomy Device for Uterine Fibroids: A Prospective Randomized Controlled Trial

A Study on the Safety and Efficacy of Laparoscopic Specialized Myomectomy Device for Uterine Fibroids: A Prospective Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120592
Enrollment
Unknown
Registered
2026-03-17
Start date
2026-03-20
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

Uterine fibroids

Interventions

Experimental group:Using laparoscopic myomectomy device
Control group:Conventional laparoscopic myomectomy without the use of laparoscopic myomectomy device

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. The patient was diagnosed with uterine fibroids after undergoing ultrasound and other imaging examinations; 2. Ultrasound confirmed that the diameter of the uterine fibroids was <= 10 cm, and the number of fibroids was <= 5, all of which were intramural fibroids; 3. The patient's age was between 18 and 55 years old; 4. There were indications for laparoscopic myomectomy; 5. The patient had no history of uterine surgery; 6. The patient had signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with concurrent gynecological malignancies or endometriosis and other diseases; 2. Patients with concurrent diseases of other vital organs such as the heart and liver; 3. Patients with a history of multiple pelvic and abdominal surgeries and concurrent severe pelvic adhesions; 4. Patients with concurrent periumbilical infections.

Design outcomes

Primary

MeasureTime frame
Intraoperative blood loss;The time for the removal of a single fibroid;The surgeon's subjective feeling score;Surgical complications;Length of hospital stay;Postoperative flatus time;The degree of postoperative hemoglobin decline;Visual analogue scale score;

Secondary

MeasureTime frame
Hemoglobin changes;Pregnancy outcome;Postoperative pregnancy situation;Postoperative symptom improvement;

Countries

China

Contacts

Public ContactGuo Ruixia

The First Affiliated Hospital of Zhengzhou University

grxcdxzzu@163.com+86 135 2556 9376

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026