Laparoscopic Myomectomy Based on a Fully Enclosed Protective Device: A Novel Surgical Technique Achieving Tumor-Free Protection Throughout the Entire Procedure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Bag integrity and absence of tissue leakage
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 28 Years to 46 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Outcomes
Primary Outcomes
Bag integrity and absence of tissue leakage
Time Frame: Intraoperative and immediately after surgery
Assessment of whether the protective bag remains intact without rupture or leakage during the procedure.
Secondary Outcomes
- Postoperative hospital stay(Perioperatively (from surgery up to hospital discharge, within 7 days))
- Postoperative complications(From the day of surgery through 30 days postoperatively)
- Operative time(During surgery)
- Intraoperative blood loss(During surgery)
- Fibroid size(Immediately after surgical removal and confirmed by pathology)
- Histopathological diagnosis(Immediately after surgical removal, confirmed by postoperative pathology)
Investigators
Chang Zhou
Doctor of Obstetrics and Gynecology
China-Japan Friendship Hospital