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

West China Second University Hospital

Status: Active, not recruiting

Conditions: Uterine Fibroid; Uterine Sarcoma; Uterine Leiomyosarcoma

Treatments: Procedure: TU-LESS; Procedure: MPLS

Study type: Interventional

Funder types: Other

Identifiers

NCT06244251

2023YFS0046

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

5,000 participants in 2 patient groups

TU-LESS for myomectomy

Experimental group

Description:

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.

Treatment:

Procedure: TU-LESS

MPLS for myomectomy

Active Comparator group

Description:

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.

Treatment:

Procedure: MPLS