Comparison Between Laparoendoscopic Single-site Surgery and Multi-port Laparoscopy in Treating Uterine Fibroids
NCT ID: NCT06244251
Last Updated: 2024-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
5000 participants
INTERVENTIONAL
2023-06-24
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TU-LESS for myomectomy
Patients complaint of symptoms resulting from uterine fibroids, such as abnormal vaginal bleeding, frequent micturition, lower abdominal pain, constipation, etc or patients with uterine fibroids which were identified accidentally during routine body examination who consulted at our center for surgical removal of the fibroids. In the meantime, the diagnosis of uterine fibroids should be reconfirmed by at least one radiological examination at our center. The patients in the experiment group were those who received transumbilical laparoendoscopic single site surgery (TU-LESS) for myomectomy.
TU-LESS
TU-LESS group will receive TU-LESS for myomectomy; MPLS group will receive MPLS for myomectomy
MPLS for myomectomy
Patients complaint of symptoms resulting from uterine fibroids, such as abnormal vaginal bleeding, frequent micturition, lower abdominal pain, constipation, etc or patients with uterine fibroids which were identified accidentally during routine body examination who consulted at our center for surgical removal of the fibroids. In the meantime, the diagnosis of uterine fibroids should be reconfirmed by at least one radiological examination at our center. The patients in the experiment group were those who received multiport laparoscopic surgery (MPLS) for myomectomy.
MPLS
Patients with uterine who plan to receive MPLS for myomectomy
Interventions
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TU-LESS
TU-LESS group will receive TU-LESS for myomectomy; MPLS group will receive MPLS for myomectomy
MPLS
Patients with uterine who plan to receive MPLS for myomectomy
Eligibility Criteria
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Inclusion Criteria
* will consider TU-LESS or MPLS for myomectomy
Exclusion Criteria
FEMALE
No
Sponsors
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West China Second University Hospital
OTHER
Responsible Party
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Zheng Ying
Dean, Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University
Locations
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West China Second University Hospital
Chengdu, Sichuan, China
Countries
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References
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Wright JD, Tergas AI, Burke WM, Cui RR, Ananth CV, Chen L, Hershman DL. Uterine pathology in women undergoing minimally invasive hysterectomy using morcellation. JAMA. 2014 Sep 24;312(12):1253-5. doi: 10.1001/jama.2014.9005. No abstract available.
Yuan P, Shan L, Yang X, Yu F, Ge Z, Wang M, Tan H. The merging of dual umbilical port-incisions for contained morcellation in laparoscopic myomectomy. Am J Obstet Gynecol. 2023 Jul;229(1):72-74. doi: 10.1016/j.ajog.2023.03.018. Epub 2023 Mar 17.
Glaser LM, Friedman J, Tsai S, Chaudhari A, Milad M. Laparoscopic myomectomy and morcellation: A review of techniques, outcomes, and practice guidelines. Best Pract Res Clin Obstet Gynaecol. 2018 Jan;46:99-112. doi: 10.1016/j.bpobgyn.2017.09.012. Epub 2017 Sep 29.
Wang L, Deng JY, Li KP, Zhu PY. A systematic review and meta-analysis comparing robotic single-site versus multi-port myomectomy. J Robot Surg. 2023 Aug;17(4):1319-1328. doi: 10.1007/s11701-023-01597-9. Epub 2023 Apr 24.
Other Identifiers
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2023YFS0046
Identifier Type: -
Identifier Source: org_study_id
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