Laser Hysteroscopic Ablation of Submucous Myoma
Conditions
Brief summary
To evaluate feasibility and efficacy of in-office hysteroscopic ablation of submucous uterine fibroid using diode laser
Detailed 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.
Interventions
DEVICEhysteroscopic ablation of submucous uterine fibroid using diode laser
patients with symptomatic submucosal fibroids (heavy menstrual bleeding) were elected for hysteroscopy and laser ablation of the myoma
Sponsors
Ariel University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
patients with symptomatic submucosal fibroides were elected for hysteroscopy laser ablation of the fibroid
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding | before the procedure and at 3 months follow up visit | improvement of the heavy menstrual bleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fibroid volume reduction | before the procedure and at 3 months follow up visit | measure by US the reduction of the myoma size |
| changes on the myoma vascularity | before the procedure and at 3 months follow up visit | measure by 3D US Doppler Color |
Countries
Israel, Italy, Spain
Outcome results
None listed