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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04400942
Other study ID # NOM-MYOMA RES
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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