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

Sponsor
First People's Hospital of Hangzhou
Study ID
NCT07512973
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Single-channel specimen retrieval bag — DEVICE
    Extend 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 — DEVICE
    Expand 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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
May 31, 2028
Completion
May 31, 2029

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Single-channel specimen retrieval bag
    Routine laparoscopic myomectomy will be performed, with the myoma specimen retrieved using a single-channel retrieval bag and a morcellator equipped with a fibroid limiter during the operation.
  • Active Comparator: Double-channel specimen retrieval bag
    Routine laparoscopic myomectomy will be performed, with the myoma specimen retrieved using a double-channel retrieval bag and a morcellator equipped with a fibroid limiter during the operation.

Primary Outcome Measure

The total duration of the patient's surgery [ Time Frame: From the time of surgical incision to the time of surgical closure, assessed intraoperatively during the index surgery ]

Central Contacts

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