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.
Patients with uterine fibroids who meet the surgical criteria.
Aged 18 and above but below 45, those who firmly request to retain the uterus.
Patients planning to undergo laparoscopic removal of uterine fibroids.
Those who understand the purpose, procedures, possible risks of this trial, voluntarily participate in this study, and sign the informed consent form.
Patients whose overall condition cannot tolerate laparoscopic surgery.
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).
Considering the possibility of malignant transformation of uterine fibroids preoperatively.
Preoperative diagnosis is unclear and needs to be differentiated from ovarian tumors.
Parallel
Single-channel specimen retrieval bag
DeviceExtend the right lower abdominal incision to 15mm, replace the disposable trocar with a 15mm one. Insert the single-channel bag (50% high-transparency, oriented to umbilicus) into the pelvis; it opens automatically. Place the specimen, tighten the opening, and pull out through the trocar. Remove and reinsert the trocar through the bag opening (avoid damage; transparent side cephalad). Insufflate CO₂ (12-15mmHg) via the right lower trocar. Connect the umbilical trocar to suction, insert the camera, maintain negative pressure, and attach tightly to the bag for visualization. Insert the morcellator with a fibroid limiter via the right lower trocar. Grasp, morcellate, and remove the specimen. Deflate, extract the bag, irrigate with normal saline to check airtightness. Replace the trocar and continue surgery.
Double-channel specimen retrieval bag
DeviceExpand the incision in the right lower abdomen to 15 mm and replace it with a 15 mm disposable cannula. Insert a dual-channel bag, place the specimen inside, and tighten the primary incision. Under laparoscopy, identify the second slender incision, switch the camera to the lower right cannula, and pull out the second incision through the umbilical cannula (to avoid twisting). Reinsert two cannulas into the respective incisions through the two openings of the bag (to prevent damage to the bag). Insufflate carbon dioxide through the umbilical cannula at a pressure of 12-15 mmHg and insert the camera. Insert an electric morcellator through the lower right cannula for fragmenting and extracting the specimen. After extraction, deflate, close the second incision, and remove the bag. Rinse with saline to check for sealing integrity. Replace the two cannulas and the camera, then continue with the surgery.
The total duration of the patient's surgery
Document the surgical procedure's commencement (time of surgical incision) and completion (time of surgical closure) times, and subsequently compute the duration from incision to closure in minutes.
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