OPPIuM Technique and Myolysis With Diode Laser Dwls

Summary

PURPOSE OF THE STUDY The study aims to examine the feasibility and effectiveness of the OPPIuM technique combined with myolysis using the DWLS diode laser. In addition, to evaluate the reduction of myoma volume and the extent of uterine bleeding with myolysis to improve women's quality of life and avoid resectoscope hysteroscopy for a G2 MIOMA, which may lead to an increase in intraoperative surgical risks and long-term complications.

POPULATION 35 patients aged between 18 and 48 years with clinical and/or ultrasound diagnosis of uterine fibromatosis, belonging to the Endometriosis/Pelvic Chronic Pain Centre of the Complex Operating Unit of Gynecology of the University Polyclinic of Monserrato and other centers involved in the study. To be eligible for inclusion, patients with ultrasound and hysteroscopic diagnosis of a single submucosal myoma, partially intramural (G1 or G2) ≤ 3 cm, must present symptoms such as abnormal uterine bleeding and pelvic pain, for which surgical treatment was scheduled.

INCLUSION CRITERIA

* Women between 18 and 48 years old
* Diagnosis of symptomatic uterine fibromatosis (abnormal uterine bleeding and/or pelvic pain) with single fibroma ≤ 3 cm G1 or G2.

EXCLUSION CRITERIA Patients who cannot provide written informed consent or follow the procedures set out in the protocol.

* Patients with malignant neoplasms or serious systemic diseases
* Patients with multiple fibroids or single \> 3 cm
* Asymptomatic patients
* Patients with other uterine or related diseases
* Patients seeking a pregnancy. INTERVENTION STRATEGY AND INSTRUMENTS

A total of 35 women will initially be included in the study, of which:

Patients will undergo the following assessments:

* Collection of physiological, pathological, and pharmacological anamnesis
* Collection of diagnostic tests (ultrasound) and staging of the underlying disease (uterine fibromatosis)
* Completion of the PBAC questionnaire
* Transvaginal ultrasound
* Office diagnostic hysteroscopy with OPPIuM and Myolysis
* Possible resectoscope hysteroscopy or laser myomectomy in narcosis.

Conditions

• Uterine Fibroid
• Myoma;Uterus

Interventions

PROCEDURE

hysteroscopy

OPPIum and Myolysis

Sponsors & Collaborators

• University of Foggia

  collaborator OTHER

• Azienda Ospedaliera Ordine Mauriziano di Torino

  collaborator OTHER

• Civic Hospital, Italy

  collaborator OTHER

• Clinical Hospital Center Rijeka

  collaborator OTHER

• BelMedic Hospital, Beograd, Serbia

  collaborator UNKNOWN

• University of Cagliari

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

48 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-09-01

Primary Completion

2021-09-01

Completion

2022-01-01

Countries

• Italy

Study Locations