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The goal of this observational study is to evaluate the feasibility, safety, and effectiveness of a fully enclosed protective device system in laparoscopic myomectomy to achieve tumor-free protection throughout the entire surgical procedure in women aged 28-46 years diagnosed with uterine fibroids who require laparoscopic myomectomy.
The main questions it aims to answer are:
Can the fully enclosed protective device system successfully achieve complete physical isolation of fibroid tissue during laparoscopic myomectomy and morcellation?
Does the use of this device reduce the risk of tissue dissemination or leakage while maintaining acceptable surgical outcomes such as operative time, blood loss, and postoperative recovery?
Participants will undergo laparoscopic myomectomy assisted by the fully enclosed protective device system. During the procedure, participants will:
undergo laparoscopic removal of uterine fibroids using a fully enclosed protective isolation system
have the fibroid dissected and contained within a protective bag during the entire procedure
receive in-bag morcellation or fragmentation of fibroid tissue within a sealed environment
be evaluated for operative outcomes including fibroid size, operative time, intraoperative blood loss, integrity of the protective bag, and postoperative hospital stay
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic Myomectomy with Fully Enclosed Protective Device | This cohort includes women diagnosed with uterine fibroids who underwent laparoscopic myomectomy assisted by a fully enclosed protective device system designed to achieve tumor-free protection throughout the entire surgical procedure. During the operation, a specialized high-strength protective bag is introduced into the pelvic cavity before fibroid dissection. The fibroid is separated from the uterine wall while being supported and contained within the protective bag. After removal, the fibroid is completely isolated within the bag, and in-bag morcellation or tissue fragmentation is performed within a sealed environment with an independent pneumoperitoneum, preventing tissue or fluid leakage into the abdominal cavity. The intervention aims to maintain the oncological "tumor-free principle" throughout the procedure, reduce the risk of tissue dissemination, and improve surgical safety during laparoscopic myomectomy. Participants in this cohort were evaluated for surgical outcomes in |
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| Measure | Description | Time Frame |
|---|---|---|
| Bag integrity and absence of tissue leakage | Assessment of whether the protective bag remains intact without rupture or leakage during the procedure. | Intraoperative and immediately after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Total duration of the surgical procedure | During surgery |
| Intraoperative blood loss | Estimated blood loss measured in milliliters |
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Inclusion Criteria:
Female patients aged 28 to 46 years Diagnosis of uterine fibroids confirmed by pelvic ultrasound and magnetic resonance imaging (MRI) Maximum diameter of the dominant fibroid between 6 and 10 cm Scheduled to undergo laparoscopic myomectomy Preoperative evaluation consistent with benign uterine fibroids Able and willing to provide written informed consent
Exclusion Criteria:
Suspicion of uterine malignancy based on imaging findings or clinical assessment Presence of severe systemic disease contraindicating laparoscopic surgery Current pregnancy Inability or unwillingness to provide informed consent
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The study population includes female patients with uterine fibroids undergoing laparoscopic myomectomy at a single center between April 2025 and March 2026. Eligible participants are women aged 28 to 46 years with fibroids measuring 6 to 10 cm in diameter and preoperative findings consistent with benign disease.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | No. 2, Xinghua East Street, Chaoyang District | 100020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19701042 | Background | Kho KA, Nezhat C. Parasitic myomas. Obstet Gynecol. 2009 Sep;114(3):611-615. doi: 10.1097/AOG.0b013e3181b2b09a. | |
| Background | Cohen SL, Greenberg JA, Wang KC, et al. Risk of dissemination of occult uterine malignancy during laparoscopic morcellation. JAMA. 2014 | ||
| Background | U.S. Food and Drug Administration. Quantitative Assessment of the Prevalence of Uterine Sarcoma in Women Undergoing Treatment of Uterine Fibroids. FDA Safety Communication. |
| Label | URL |
|---|---|
| General information about uterine fibroids and laparoscopic surgery | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
Individual participant data (IPD) from this study will not be publicly shared because the dataset contains identifiable clinical information from a small number of patients treated at a single institution. Public release of these data may increase the risk of patient re-identification and compromise participant privacy. In addition, the study was conducted as a retrospective analysis and the informed consent obtained from participants did not include permission for public sharing of individual-level data. Therefore, to protect patient confidentiality and comply with institutional ethics policies, IPD will not be made publicly available.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2026 | Mar 4, 2026 |
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| During surgery |
| Fibroid size | Maximum diameter of the removed uterine fibroid measured intraoperatively and confirmed by postoperative pathology | Immediately after surgical removal and confirmed by pathology |
| Postoperative hospital stay | Length of postoperative hospital stay measured in days | Perioperatively (from surgery up to hospital discharge, within 7 days) |
| Postoperative complications | Incidence of postoperative complications such as infection, fever, or pelvic inflammation | From the day of surgery through 30 days postoperatively |
| Histopathological diagnosis | Confirmation of the pathological type of removed fibroids by postoperative pathology | Immediately after surgical removal, confirmed by postoperative pathology |
| China-Japan Friendship Hospital official website | View source |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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