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Single-channel fibroid morcellation system used in clinical research on laparoscopic myomectomy.

Single-channel fibroid morcellation system used in clinical research on laparoscopic myomectomy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122857
Enrollment
Unknown
Registered
2026-04-20
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-04-27

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:Single-channel specimen retrieval bag
Control group:Double-channel specimen retrieval bag

Sponsors

Affiliated hangzhou first people's hospital, zhejiang university school of medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

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

Exclusion criteria: 1.Patients whose overall condition cannot tolerate laparoscopic surgery. 2.Patients with multiple fibroids, with a total number of fibroids >= 4 and a maximum diameter of a single fibroid >= 10cm. 3.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). 4.Considering the possibility of malignant transformation of uterine fibroids preoperatively. 5.Preoperative diagnosis is unclear and needs to be differentiated from ovarian tumors. 6.History of previous lower abdominal surgery or severe pelvic or abdominal adhesions. 7.Presence of untreated infectious sexual diseases, including but not limited to vaginitis, cervicitis, and pelvic inflammatory disease. 8.Patients who cannot understand the research protocol, cooperate with the study procedures and follow-up, and any other patients deemed unsuitable for participation in this study by the researchers.

Design outcomes

Primary

MeasureTime frame
Total surgical time;Time of Uterine Fibroid Removal;

Secondary

MeasureTime frame
Placement Success Rate;Intraoperative Rupture and Leakage Rate;Gynecologic Surgeon Satisfaction with the Procedure (Appendix 1);Total Weight of Uterine Fibroid Fragments Removed;Weight and Number of Residual Tissue Fragments in the Abdominal Cavity;Cytological examination of peritoneal lavage fluid before and after morcellation for the presence of spindle cells or tumor cells.;Intraoperative Blood Loss;Intraoperative Complications (Perforation of the endometrium, injury to major blood vessels, nerves, and organs, etc.);Postoperative Complications (Postoperative major bleeding, urinary retention);Preoperative and Postoperative Hemoglobin Levels;Postoperative Fibroid Recurrence Rate;Intraoperative and Postoperative Blood Transfusion Rate;Postoperative Length of Hospital Stay and Hospitalization Costs;

Countries

China

Contacts

Public ContactYahui Wang

Affiliated hangzhou first people's hospital, zhejiang university school of medicine

362303714@qq.com+86 571 5600 6992

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026