Predictive Factors for Complete Myoma Resection During Hysteroscopic Myomectomy

Study Overview
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Brief Summary
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The aim of this observational retrospective analysis is to evaluate predictive factors for complete myoma resection during hysteroscopic myomectomy for developing and validating a nomogram. This tool can help clinicians to support the patient in making an informed decision about therapeutic options for uterine submucous myomas by defining risk factors predicting a high complexity myomectomy.

Detailed Description
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Overall, 10% of all uterine myomas are submucosal. These myomas spread into the uterine cavity, lifting the endometrial mucosa, and are a common cause of abnormal uterine bleeding, dysmenorrhea, early miscarriage and they may be a cause of infertility. Hysteroscopic myomectomy is the surgical procedure of choice for the treatment of submucosal myomas, because it is minimally invasive and has the advantage of preserving the integrity of the uterine wall. The characteristics of the myomas (size, number and location) enables the surgeon to choose the surgical approach that will provide the best outcome for the patient, and may predict the chances of a complete hysteroscopic resection of myomas in one procedure.

Official Title
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A Retrospective Study for Developing a Nomogram for Predicting Change of Complete Myoma Resection During Hysteroscopic Myomectomy

Conditions
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Uterine Fibroids, Uterine Myomas

Intervention / Treatment
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* Diagnostic Test: Transvaginal ultrasound
* Behavioral: Anamnesis
* Procedure: Operative hysteroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with ultrasonographic diagnosis of uterine myomas Exclusion Criteria: patients with previous incomplete hysteroscopic myoma resection; patients undergoing additional surgical procedures performed by hysteroscopy (such as, resection of endometrial polyps); patients undergoing associated non-hysteroscopic surgical procedures; patients with severe cardiovascular disease, decompensated diabetes and severe hematologic disorders

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with uterine myomas undergoing hysteroscopic myomectomy<br> | Diagnostic Test: Transvaginal ultrasound<br>* Transvaginal ultrasonographic scan aims to evaluate number, size (diameter and volume), location and appearance of submucous uterine myomas, concomitant presence of adenomyosis<br>Behavioral: Anamnesis<br>* Anamnesis aims to collect data about age, BMI, previous hormonal therapies (such as ulipristal acetate or gonadotropin-releasing hormone agonists) with submucous uterine myomas<br>Procedure: Operative hysteroscopy<br>* Operative hysteroscopy allows a direct evaluation of number, size (diameter and volume), location and appearance of submucous uterine myomas. This exam allows the resection of the myomas.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with complete resection of myomas |  | At the end of the hysteroscopic procedure |