Predictive Factors for Complete Myoma Resection During Hysteroscopic Myomectomy

• Conditions: Uterine Myomas; Uterine Fibroids
• Interventions: Diagnostic Test: Transvaginal ultrasound; Behavioral: Anamnesis; Procedure: Operative hysteroscopy

• Registration Number: NCT04400942
• Lead Sponsor: Ospedale Policlinico San Martino

Brief 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.

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-26
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-03
• Last Update Posted: 2021-03-04
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with uterine myomas undergoing hysteroscopic myomectomy	Transvaginal ultrasound	-
Women with uterine myomas undergoing hysteroscopic myomectomy	Anamnesis	-
Women with uterine myomas undergoing hysteroscopic myomectomy	Operative hysteroscopy	-

Primary Outcome Measures

Name	Time	Method
Number of patients with complete resection of myomas	At the end of the hysteroscopic procedure

Trial Locations

Locations (1)

IRCCS Ospedale Policlinico San Martino; 🇮🇹 Genoa, Italy