Single-channel Fibroid Morcellation System Used in Clinical Research on Laparoscopic Myomectomy

Single-channel Fibroid Morcellation System Used in Clinical Research on Laparoscopic

This prospective, single-center, randomized, single-blind controlled trial aims to evaluate the efficacy and safety of a novel single-channel retrieval bag compared to a widely used dual-channel retrieval bag in laparoscopic myomectomy. A total of 78 patients aged 18 to 45 years with uterine fibroids (diameter ≥ 4 cm and requiring preservation of the uterus) will be randomly assigned to the experimental group and the control group in a 1:1 ratio. The experimental group will use the single-channel system (an upgraded high-transparency large-capacity retrieval bag + fragmentation device with a fibroid limiter), while the control group will utilize a standard dual-channel bag + fragmentation device with a fibroid limiter. The primary outcome measure will be the total surgical time. Secondary outcome measures will include the success rate of placement, intraoperative leakage rate, surgeon's learning curve, and intraoperative/postoperative complications. Patients will be followed up at 3 months, 6 months, 12 months, and 24 months to assess recurrence and the risk of fibroid dissemination. Preliminary data (n = 22) indicate that the single-channel myomectomy fragmentation system significantly reduced total sampling time (15.4 minutes vs. 36.7 minutes, p = 0.005) while demonstrating comparable safety. This study utilizes the same electric fragmentation device for both the experimental and control groups, with the experimental group employing a further upgraded single-channel retrieval bag to verify the advantages of the novel single-channel retrieval bag in simplifying surgical procedures, improving efficiency, and providing a smoother learning curve, thereby offering evidence for its clinical promotion and patent conversion, particularly suitable for primary care hospitals.

This prospective, single-center, randomized, single-blind controlled trial aims to systematically compare the clinical application performance of a newly upgraded single-channel endoscopic sampling bag with a clinically widely used dual-channel sampling bag in laparoscopic myomectomy. Both groups utilized the same standardized electrical lithotripsy device and were equipped with a uterine fibroid positioning device to ensure that the primary variables of the study were only related to the design and performance differences between the two types of sampling bags, thereby enhancing the reliability of the comparative analysis.

The experimental group used an upgraded disposable endoscopic specimen sampling bag (patent application number: CN202311181558.X, Hangzhou Kangji Medical Equipment Co., Ltd.), which has been sterilized with ethylene oxide to meet clinical sterility requirements. This sampling bag consists of four core components: the bag body, sleeve, mechanical opening device, and an adjustable tension pull string, allowing for minimally invasive insertion into the abdominal cavity via a standard puncture device. Based on preliminary research, this upgraded version has undergone targeted structural optimization to address key clinical issues. Notably, the main body of the bag uses a dual-material composite design: 50% of its surface area is composed of ultra-thin, high-transparency thermoplastic polyurethane (TPU), while the remaining 50% utilizes biocompatible material identical to that of the traditional dual-channel retrieval bags used in the control group. This mixed design balances functional performance and clinical adaptability. Key improvements include optimized materials and a folding mechanism that resolves adhesion issues present in the initial version (the initial version's entire bag body was made of ultra-thin high-transparency TPU, which, when folded and compressed, expels air creating negative pressure suction, while intermolecular forces cause the membranes to stick together). This problem hampered deployment within the abdominal cavity and required assistance from laparoscopic instruments (with the risk of tearing or perforation). The revised folding structure reduces interlayer adhesion, allowing the bag to open more easily in the abdominal cavity without excessive instrumental manipulation, thus enhancing operational efficiency and safety.

While retaining its core functional advantages, the upgraded single-channel bag maintains the characteristic of the coupling effect: when the endoscopic lens is moistened with saline and closely adheres to the high-transparency TPU area, an optical coupling interface is formed, enabling clear observation of the internal specimens and the fragmentation process without needing to insert the lens into the bag. This non-invasive observation mode simplifies operational coordination and reduces the risk of bag damage. Additionally, the bag features a large capacity design with an opening diameter of 15 centimeters and an internal capacity of 2500 milliliters. By inflation with medical gases, the expanded bag can effectively displace intestinal loops, minimize intraoperative tissue interference, reduce the risk of damage to adjacent organs, and optimize the surgical field for precise fragmentation and specimen retrieval.

In contrast, the control group used an established dual-channel retrieval bag in clinical practice, which requires dedicated channels for instrument insertion and endoscopic observation. The process of inserting it into the abdominal cavity typically requires more active instrumental assistance compared to the upgraded single-channel bag.

For both patient groups, the surgical procedure followed standardized laparoscopic myomectomy protocols, performed by surgeons with at least 5 years of relevant clinical experience to ensure consistency in surgery. After myomectomy, specimens were placed into the corresponding retrieval bags under endoscopic guidance. The experimental group completed fragmentation and retrieval through the opening of the single-channel bag using the built-in fragmentation device, taking advantage of the bag's self-expanding and clear visibility features; the control group, on the other hand, operated through dual-channel cooperative procedures, adhering to standard clinical workflows of the dual-channel system. All critical operational steps and measurements related to outcomes (such as placement time and fragmentation duration) were recorded by designated researchers using standardized data collection forms to ensure accuracy and comparability. This study aims to validate how structural and material optimization measures of the new single-channel retrieval bag translate into clinical benefits, including streamlining operational processes, improving the success rate of deployment, shortening the learning curve, and enhancing surgical efficiency-while maintaining a safety level comparable to traditional dual-channel systems. The findings are expected to provide strong clinical evidence for the promotion and application of the upgraded single-channel retrieval bag.

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:

1. Patients whose overall condition cannot tolerate laparoscopic surgery.
2. 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).
3. Considering the possibility of malignant transformation of uterine fibroids preoperatively.
4. Preoperative diagnosis is unclear and needs to be differentiated from ovarian tumors.
5. History of previous lower abdominal surgery or severe pelvic or abdominal adhesions.
6. Presence of untreated infectious sexual diseases, including but not limited to vaginitis, cervicitis, and pelvic inflammatory disease.