Clinical trial NCT04400942: Predictive Factors for Complete Myoma Resection During Hysteroscopic Myomectomy
Official title: A Retrospective Study for Developing a Nomogram for Predicting Change of Complete Myoma Resection During Hysteroscopic Myomectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uterine Fibroids
Uterine Myomas
Lead sponsor: Ospedale Policlinico San Martino
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with trasonographic diagnosis of uterine myomas undergoing hysteroscopic myomectomy

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.

Eligibility 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

Primary outcomes:
measure: Number of patients with complete resection of myomas
timeFrame: At the end of the hysteroscopic procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
Study officials:
References:
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.
citation: 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.