Predictive Factors for Complete Myoma Resection During Hysteroscopic Myomectomy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Women with uterine myomas undergoing hysteroscopic myomectomy
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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.
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Outcome Measures
Primary Outcome Measures
- Number of patients with complete resection of myomas [At the end of the hysteroscopic procedure]
Eligibility Criteria
Criteria
Inclusion Criteria:
- patients with ultrasonographic diagnosis of uterine myomas
Exclusion Criteria:
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patients with previous incomplete hysteroscopic myoma resection;
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patients undergoing additional surgical procedures performed by hysteroscopy (such as, resection of endometrial polyps);
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patients undergoing associated non-hysteroscopic surgical procedures;
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patients with severe cardiovascular disease, decompensated diabetes and severe hematologic disorders
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IRCCS Ospedale Policlinico San Martino | Genoa | Italy | 16132 |
Sponsors and Collaborators
- Ospedale Policlinico San Martino
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- NOM-MYOMA RES