In-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids

Ariel University

Status: Completed

Conditions: Laser Hysteroscopic Ablation of Submucous Myoma

Treatments: Device: hysteroscopic ablation of submucous uterine fibroid using diode laser

Study type: Interventional

Funder types: Other

Identifiers

NCT05604001

LaMyA

Details and patient eligibility

About

To evaluate feasibility and efficacy of in-office hysteroscopic ablation of submucous uterine fibroid using diode laser

Full description

A pilot study was conducted between January 2018 and January 2019 in a tertiary care university hospital. Patients with at least one symptomatic, class 0-2 of FIGO classification, uterine fibroid of ≤ 7cm in size were eligible for inclusion. Evaluation of the changes in fibroid size and vascularity was performed using 3D Doppler ultrasonography. Vaporization of the fibroid core was conducted using a 1470nm wavelength diode laser inserted through the hysteroscope's working channel. Primary outcome was the evaluation of the fibroid volume before and at 2 months after the procedure.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• symptomatic patients without desire of future fertility (symptoms included heavy menstrual bleeding, abdominal discomfort, bulk symptoms such as urinary frequency, pelvic pressure and constipation),
• grade 0-2 (FIGO classification) ≤ 7cm fibroids with evident vascularity seen by 3D-DS compared to its adjacent myometrial tissue

Exclusion criteria

• intramural fibroids (FIGO class 3 or more),
• >2 submucosal fibroids,
• pelvic inflammatory disease,
• known gynecologic malignancy,
• severe cervical stenosis,
• pregnancy
• desire of future fertility,
• previous cervical surgery

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Symptomatic submucosal myoma

Experimental group

Description:

patients with symptomatic submucosal fibroids (heavy menstrual bleeding) were elected for hysteroscopy with laser ablation of the myoma.

Treatment:

Device: hysteroscopic ablation of submucous uterine fibroid using diode laser