Predictive Factors for Complete Myoma Resection During Hysteroscopic Myomectomy

Uterine Fibroids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04400942
• Other study ID #: NOM-MYOMA RES
• Status: Recruiting
• Start date: January 1, 2015
• Est. completion date: December 1, 2021

Study information

• Verified date: March 2021
• Source: Ospedale Policlinico San Martino
• Contact: Simone Ferrero, MD, PhD
• Phone: 0039010511525
• Email: simone.ferrero[@]unige.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Myoma
• Uterine Fibroids
• Uterine Myomas

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS Ospedale Policlinico San Martino	Genoa

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Policlinico San Martino

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with complete resection of myomas		At the end of the hysteroscopic procedure