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Trial Title:
Comparison Between Laparoendoscopic Single-site Surgery and Multi-port Laparoscopy in Treating Uterine Fibroids
NCT ID:
NCT06244251
Condition:
Uterine Fibroid
Uterine Sarcoma
Uterine Leiomyosarcoma
Conditions: Official terms:
Leiomyoma
Myofibroma
Leiomyosarcoma
Conditions: Keywords:
Uterine fibroids
TU-LESS
Multi-port laparoscopic surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
TU-LESS
Description:
TU-LESS group will receive TU-LESS for myomectomy; MPLS group will receive MPLS for
myomectomy
Arm group label:
TU-LESS for myomectomy
Intervention type:
Procedure
Intervention name:
MPLS
Description:
Patients with uterine who plan to receive MPLS for myomectomy
Arm group label:
MPLS for myomectomy
Summary:
Myomectomy was preferably applied in females with reproductive requirements, which could
be achieved by transumbilical laparoendoscopic single-site surgery (TU-LESS) or
multi-port laparoscopic surgery (MPLS). Power morcellation used in MPLS was correlated
with unidentified risk of tumor dissemination, especially in cases with accidental
surgical findings of uterine sarcoma or leiomyosarcoma. Moreover, TU-LESS was reported to
exceed MPLS in fast recovery. Therefore, the aim of this prospective cohort study is to
compare the effectiveness of fast recovery and relative risk of tumor dissemination
between TU-LESS and MPLS in myomectomy for the treatment of uterine fibroids.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- diagnosed with uterine fibroids before surgery on the basis of radiological or other
examinations
- will consider TU-LESS or MPLS for myomectomy
Exclusion Criteria:
- patients reluctant to long-term follow-up
Gender:
Female
Gender based:
Yes
Gender description:
Uterine fibroids occur only to female population
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Second University Hospital
Address:
City:
Chengdu
Zip:
610041
Country:
China
Start date:
June 24, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
West China Second University Hospital
Agency class:
Other
Source:
West China Second University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06244251
