Office Preparation of Partially Intramural Uterine Myomas (OPPIuM) and Myolysis With Diode Laser Dual Wavelengths Laser System (DWLS) for the Treatment of G1-G2 Symptomatic Myomas
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Evaluation of symptoms decrease
研究概览
简要总结
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.
详细描述
BACKGROUND Leiomyomas or uterine fibroids are benign lesions that can cause infertility, uterine bleeding (hypermenorrhea, metrorrhagia, and menometrorrhagia), resulting in anemia, disorders in urinary tract function and symptoms of abdominal pressure, chronic pelvic pain, and/or dysmenorrhea. Often doctors decide to remove the myoma or uterus to resolve the symptoms. Myomas or uterine fibroids occur in 25 to 44% of women during reproductive age. Myomas are more common in the fourth and fifth decade of life when their incidence can reach almost 70% in Caucasian women and over 80% in African origin women.
Submucosal fibroids are classified according to their development within the endometrial cavity in G0: intracavitary pedunculate fibroids G1 : fibromas whose intramural development is less than 50%. G2 : fibromas whose intramural development is greater than or equal to 50%. Resectoscope myomectomy for G2 myomas is a difficult procedure that should only be performed by surgeons experienced in hysteroscopy. In fact, resectoscope hysteroscopy is associated with a significant risk of complications that is proportional to the degree of intramural development of the myoma. Furthermore, the greater the myoma and its intramural development, the more likely the procedure will need to be divided into several surgical interventions.
As a result of these problems, several myolysis techniques have developed in which myomas are coagulated rather than removed using electrical energy or laser (thermomyolysis), liquid nitrogen (cryomyolysis), or recently even ultrasound.
Myolysis was performed for the first time by Mergui in France in 1987 using laser YAG to create holes in the myomas resulting in necrosis and narrowing. Later Leukens and Gallinat, in 1993, used bipolar needles from 1 to 3 cm to perform myolysis; their technique was similar to Mergui's.
In 2009 Bettocchi et al. evaluated the efficacy of a procedure to prepare submucosal fibromas with partially intramural development (G1 and G2) >1.5 cm in an outpatient setting (OPPIuM) to facilitate subsequent resectoscope hysteroscopic removal with the patient under general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between 18 and 48 years old
- •Diagnosis of symptomatic uterine fibromatosis (abnormal uterine bleeding, pelvic pain and/or infertility) with single fibroma ≤ 3 cm G1 or G2.
排除标准
- •Patients who are unable to provide written informed consent or to 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 for a pregnancy.
结局指标
主要结局
Evaluation of symptoms decrease
时间窗: 3 months
Change from baseline in symptoms on PBAC score (Herman MC et al.) at 3 months
次要结局
- Evaluation of myoma volume reduction(3 months)
研究者
Stefano Angioni
Full Professor
University of Cagliari