Comparison Between Laparoendoscopic Single-site Surgery and Multi-port Laparoscopy in Treating Uterine Fibroids

Uterine Fibroid Clinical Trial

Official title:

Comparison of Operational Outcomes and Long-term Benefits Between Laparoendoscopic Single-site Surgery and Multi-port Laparoscopy in Treating Uterine Fibroids

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06244251
• Other study ID #: 2023YFS0046
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 24, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: West China Second University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2026
• Est. primary completion date: August 24, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Leiomyosarcoma
• Uterine Fibroid
• Uterine Leiomyosarcoma
• Uterine Sarcoma

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
China	West China Second University Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Second University Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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 201 — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Objective evaluation of incision healing	The patients will be asked to give rating of the recovery of surgical incision from 1 (the most unsatisfied) to 10 (the most satisfied) through questionnaire and telephone follow up.	From enrollment to 3 months after myomectomy.
Primary	Duration of hospital stay after surgery	The number of days between myomectomy and the day of hospital discharge.	From enrollment to 1 month after receiving myomectomy
Secondary	VAS score at 4, 8, 12, 16, 20, 24 hours after myomectomy	The visual analogue score at 4, 8, 12, 16, 20, 24 hours after myomectomy will be collected through questionnaire.	From enrollment to 24 hours after myomectomy
Secondary	Time between myomectomy and exhaustion	The exact time between myomectomy and exhaustion will be collected during wards round by directly asking the patients.	From enrollment to 1 week after myomectomy.
Secondary	Time of surgery	The time of surgery (from superficial incision to the end of umbilical suturing in experimental group and end of incision suturing in control group) will be collected during surgery.	From enrollment to 1 day after myomectomy.
Secondary	Volume of bleeding during myomectomy	The exact volume of bleeding during myomectomy in both experimental and control group will be collected during surgery.	From enrollment to 1 day after myomectomy.
Secondary	Number of uterine fibroids resected during surgery.	The exact number of uterine fibroids resected during myomectomy in both experimental and control group will be collected during surgery.	From enrollment to 1 day after myomectomy.
Secondary	Pregnancy outcome	Whether the patient had pregnancy within 2 years after myomectomy. The information will be collected through online questionnaire and telephone.	From enrollment to 2 years after myomectomy
Secondary	Occurrence of pelvic and abdominal metastasis after myomectomy in cases with accidental uterine malignancy	According to epidemiology data, a fraction of patients with primarily identified uterine fibroids will be pathologically diagnosed with uterine malignancy like uterine sarcoma after surgery. Whether the patients who were finally diagnosed with uterine malignancy based pathology developed abdominal or pelvic metastasis will be collected by telephone follow-up.	From enrollment to 2 years after receiving myomectomy