Clinical trial NCT06244251: Comparison Between Laparoendoscopic Single-site Surgery and Multi-port Laparoscopy in Treating Uterine Fibroids
Official title: Comparison of Operational Outcomes and Long-term Benefits Between Laparoendoscopic Single-site Surgery and Multi-port Laparoscopy in Treating Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Uterine Fibroid
Uterine Sarcoma
Uterine Leiomyosarcoma
Keywords: Uterine fibroids
TU-LESS
Multi-port laparoscopic surgery
Lead sponsor: West China Second University Hospital
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 5000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Duration of hospital stay after surgery
timeFrame: From enrollment to 1 month after receiving myomectomy
Secondary outcomes:
measure: VAS score at 4, 8, 12, 16, 20, 24 hours after myomectomy
timeFrame: From enrollment to 24 hours after myomectomy
measure: Time between myomectomy and exhaustion
timeFrame: From enrollment to 1 week after myomectomy.
measure: Time of surgery
timeFrame: From enrollment to 1 day after myomectomy.
measure: Volume of bleeding during myomectomy
timeFrame: From enrollment to 1 day after myomectomy.
measure: Number of uterine fibroids resected during surgery.
timeFrame: From enrollment to 1 day after myomectomy.
measure: Pregnancy outcome
timeFrame: From enrollment to 2 years after myomectomy
measure: Occurrence of pelvic and abdominal metastasis after myomectomy in cases with accidental uterine malignancy
timeFrame: From enrollment to 2 years after receiving myomectomy
Other outcomes:
measure: Objective evaluation of incision healing
timeFrame: From enrollment to 3 months after myomectomy.
Locations:
city: Chengdu
country: China
facility: West China Second University Hospital
state: Sichuan
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.