In-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids

Ariel University20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Laser Hysteroscopic Ablation of Submucous Myoma

Interventions

hysteroscopic ablation of submucous uterine fibroid using diode laserDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Laniado University Hospital

Netanya, Israel

University of Cagliari

Cagliari, Italy

universita della campagna luigi Vanvitelli

Napoli, Italy

Parc de Salut Mar

Barcelona, Spain

Outcomes

Primary Outcomes

Bleeding

improvement of the heavy menstrual bleeding

Time frame: before the procedure and at 3 months follow up visit

Secondary Outcomes

fibroid volume reduction

measure by US the reduction of the myoma size

Time frame: before the procedure and at 3 months follow up visit

changes on the myoma vascularity

measure by 3D US Doppler Color

Time frame: before the procedure and at 3 months follow up visit

Data from ClinicalTrials.gov

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