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Predictive Factors for Complete Myoma Resection During Hysteroscopic Myomectomy

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StatusRecruiting
Sponsors
Ospedale Policlinico San Martino

Keywords

Abstract

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.

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.

Dates

Last Verified: 06/30/2020
First Submitted: 05/18/2020
Estimated Enrollment Submitted: 05/20/2020
First Posted: 05/25/2020
Last Update Submitted: 07/25/2020
Last Update Posted: 07/27/2020
Actual Study Start Date: 12/31/2014
Estimated Primary Completion Date: 11/30/2020
Estimated Study Completion Date: 11/30/2020

Condition or disease

Uterine Fibroids
Uterine Myomas

Intervention/treatment

Diagnostic Test: Women with uterine myomas undergoing hysteroscopic myomectomy

Behavioral: Women with uterine myomas undergoing hysteroscopic myomectomy

Procedure: Women with uterine myomas undergoing hysteroscopic myomectomy

Phase

-

Arm Groups

ArmIntervention/treatment
Women with uterine myomas undergoing hysteroscopic myomectomy
Diagnostic Test: Women with uterine myomas undergoing hysteroscopic myomectomy
Transvaginal ultrasonographic scan aims to evaluate number, size (diameter and volume), location and appearance of submucous uterine myomas, concomitant presence of adenomyosis

Eligibility Criteria

Ages Eligible for Study 18 Years To 18 Years
Sexes Eligible for StudyFemale
Sampling methodNon-Probability Sample
Accepts Healthy VolunteersNo
Criteria

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

Outcome

Primary Outcome Measures

1. Number of patients with complete resection of myomas [At the end of the hysteroscopic procedure]

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