NCT04400942

Predictive Factors for Complete Myoma Resection During Hysteroscopic Myomectomy

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Ospedale Policlinico San Martino · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

Summary

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

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.

Conditions

• Uterine Fibroids
• Uterine Myomas

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Transvaginal ultrasound	Transvaginal ultrasonographic scan aims to evaluate number, size (diameter and volume), location and appearance of submucous uterine myomas, concomitant presence of adenomyosis
BEHAVIORAL	Anamnesis	Anamnesis aims to collect data about age, BMI, previous hormonal therapies (such as ulipristal acetate or gonadotropin-releasing hormone agonists) with submucous uterine myomas
PROCEDURE	Operative hysteroscopy	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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2020-05-26
• Last updated: 2021-03-04

Locations

1 site across 1 country: Italy