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Trial Title:
Clinical Research on the Application of Single-channel Uterine Fibroid Morcellation System in Laparoscopic Myomectomy
NCT ID:
NCT06442605
Condition:
Leiomyoma, Uterine
Conditions: Official terms:
Leiomyoma
Myofibroma
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Device
Intervention name:
single-channel uterine fibroid morcellation system
Description:
Conventional laparoscopic myomectomy is performed with the use of a single-channel
uterine fibroid morcellation system for fragmentation and retrieval of the fibroids
during the procedure.
Arm group label:
Experimental group
Intervention type:
Device
Intervention name:
Multi-channel specimen retrieval bag + conventional laparoscopic uterine fibroid morcellator
Description:
In conventional laparoscopic myomectomy, a multi-channel specimen retrieval bag is used
during the procedure, along with a conventional laparoscopic uterine fibroid morcellator
for fragmentation and retrieval of the fibroids.
Arm group label:
Control group
Summary:
Research Purpose The purpose of this study is to explore whether the application of a
single-channel uterine fibroid morcellation system compared to a multi-channel specimen
retrieval bag during laparoscopic myomectomy can shorten the operative time and improve
the efficiency of fibroid removal.
Research Design This study is a single-center, randomized, single-blind, 1:1 controlled
trial.
Intervention Measures Study participants were randomly assigned in a 1:1 ratio into two
groups.
Experimental group: Conventional laparoscopic myomectomy with the use of a single-channel
uterine fibroid morcellation system for fragmentation and retrieval of the fibroids.
Control group: Conventional laparoscopic myomectomy with the use of a multi-channel
specimen retrieval bag and a conventional laparoscopic uterine fibroid morcellator for
fragmentation and retrieval of the fibroids.
Observation Indicators Primary observation indicator: Time required for fibroid
fragmentation and retrieval (from the placement of the single-channel uterine fibroid
morcellation system or the multi-channel specimen retrieval bag to complete removal from
the abdominal cavity).
Secondary observation indicators: Success rate of placement, intraoperative damage and
leakage rate, gynecological surgeon satisfaction with the surgery, total weight of
retrieved uterine fibroid fragments.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Patients with uterine fibroids who meet the surgical indications. Patients aged 18 and
above but below 45, who strongly request to preserve the uterus.
Patients planning to undergo laparoscopic myomectomy. Those who understand the purpose,
procedures, potential risks of this trial, voluntarily participate in this study, and
sign the informed consent form.
Exclusion Criteria:
Patients who cannot tolerate laparoscopic surgery due to their overall physical
condition.
Patients with multiple fibroids have at least 4 fibroids, with the largest diameter of a
single fibroid being equal to or greater than 10cm.
Patients who require surgical procedures other than laparoscopic myomectomy (excluding
pelvic adhesion lysis, resection of mesosalpingeal cysts measuring less than 2cm, and
superficial intraperitoneal lesions resection/electrocoagulation).
Preoperatively considering the possibility of uterine fibroid malignancy. Patients with
preoperative unclear diagnosis, requiring differentiation from ovarian tumors.
Previously undergone lower abdominal or pelvic intraperitoneal surgery, or patients with
severe pelvic or abdominal adhesions.
Presence of untreated infectious sexual diseases, including but not limited to vaginitis,
cervical inflammatory diseases, and pelvic inflammatory diseases.
Patients who cannot understand the research protocol, cannot cooperate with the research
and follow-up, and any other patients that researchers deem unsuitable for participation
in this study.
Gender:
Female
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hangzhou First People's Hospita
Address:
City:
Hangzhou
Zip:
310006
Country:
China
Start date:
June 20, 2024
Completion date:
June 19, 2027
Lead sponsor:
Agency:
First People's Hospital of Hangzhou
Agency class:
Other
Source:
First People's Hospital of Hangzhou
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06442605
