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

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.

Study Overview

• Status: Recruiting
• Conditions: Uterine Fibroids; Uterine Myomas
• Intervention / Treatment: Diagnostic test: Transvaginal ultrasound; Behavioral: Anamnesis; Procedure: Operative hysteroscopy

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 Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Simone Ferrero, MD, PhD; Phone Number: 0039010511525; Email: simone.ferrero@unige.it

Study Locations

• Italy
  • Genoa, Italy, 16132
    • Recruiting
    • IRCCS Ospedale Policlinico San Martino
    • Contact: Simone Ferrero; Phone Number: +39 010 511525; Email: simone.ferrero@unige.it
    • Principal Investigator: Fabio Barra, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with trasonographic diagnosis of uterine myomas undergoing hysteroscopic myomectomy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Women with uterine myomas undergoing hysteroscopic myomectomy

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ospedale Policlinico San Martino

Publications and helpful links

General Publications

• Vargas MV, Moawad GN, Sievers C, Opoku-Anane J, Marfori CQ, Tyan P, Robinson JK. Feasibility, Safety, and Prediction of Complications for Minimally Invasive Myomectomy in Women With Large and Numerous Myomata. J Minim Invasive Gynecol. 2017 Feb;24(2):315-322. doi: 10.1016/j.jmig.2016.11.014. Epub 2016 Dec 7.
• Ferrero S, Tafi E, Racca A, Leone R, Maggiore U, Remorgida V, Venturini PL. Ulipristal Acetate Prior to High Complexity Hysteroscopic Myomectomy: Prospective Study. J Minim Invasive Gynecol. 2015 Nov-Dec;22(6S):S181. doi: 10.1016/j.jmig.2015.08.666. Epub 2015 Oct 15. No abstract available.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (ACTUAL): May 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Myoma; Leiomyoma; Myofibroma
• Other Study ID Numbers: NOM-MYOMA RES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No