Laparoscopic Myomectomy Based on a Fully Enclosed Protective Device: A Novel Surgical Technique Achieving Tumor-Free Protection Throughout the Entire Procedure

NCT07474688 | Active Not Recruiting

• 1 other identifier: 2024-KY-222
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Uterine Fibroids (Leiomyoma)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Operative time

  During surgery

• Intraoperative blood loss

  During surgery

• Fibroid size

  Immediately after surgical removal and confirmed by pathology

• Postoperative hospital stay

  Perioperatively (from surgery up to hospital discharge, within 7 days)

• Postoperative complications

  From the day of surgery through 30 days postoperatively

Study Arms (1)

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

Eligibility Criteria

• Age: 28 Years - 46 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, No. 2, Xinghua East Street, Chaoyang District, 100020, China

Location

Related Publications (3)

• Kho KA, Nezhat C. Parasitic myomas. Obstetrics & Gynecology. 2009

  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.

  BACKGROUND

Related Links

• General information about uterine fibroids and laparoscopic surgery
• China-Japan Friendship Hospital official website

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 16, 2026
• Study Start: April 4, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 4, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)