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Clinical Research on the Application of Single-channel Uterine Fibroid Morcellation System in Laparoscopic Myomectomy

China22 participantsStarted 2024-06-20

Plain-language summary

Research Purpose The purpose of this study is to explore whether the application of a single-channel uterine fibroid morcellation system compared to a multi-channel specimen retrieval bag during laparoscopic myomectomy can shorten the operative time and improve the efficiency of fibroid removal. Research Design This study is a single-center, randomized, single-blind, 1:1 controlled trial. Intervention Measures Study participants were randomly assigned in a 1:1 ratio into two groups. Experimental group: Conventional laparoscopic myomectomy with the use of a single-channel uterine fibroid morcellation system for fragmentation and retrieval of the fibroids. Control group: Conventional laparoscopic myomectomy with the use of a multi-channel specimen retrieval bag and a conventional laparoscopic uterine fibroid morcellator for fragmentation and retrieval of the fibroids. Observation Indicators Primary observation indicator: Time required for fibroid fragmentation and retrieval (from the placement of the single-channel uterine fibroid morcellation system or the multi-channel specimen retrieval bag to complete removal from the abdominal cavity). Secondary observation indicators: Success rate of placement, intraoperative damage and leakage rate, gynecological surgeon satisfaction with the surgery, total weight of retrieved uterine fibroid fragments.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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: 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 partic…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time required for fibroid fragmentation and retrieval

Timeframe: intraoperative

Trial details

NCT IDNCT06442605

SponsorFirst People's Hospital of Hangzhou

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-19

Contact for this trial

Yahui Wang

+8615158150768 362303714@qq.com

View on ClinicalTrials.gov More Leiomyoma, Uterine trials