Predictive Factors for Complete Myoma Resection During Hysteroscopic Myomectomy
NCT ID: NCT04400942
Last Updated: 2021-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
600 participants
OBSERVATIONAL
2015-01-01
2021-12-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Women with uterine myomas undergoing hysteroscopic myomectomy
Transvaginal ultrasound
Transvaginal ultrasonographic scan aims to evaluate number, size (diameter and volume), location and appearance of submucous uterine myomas, concomitant presence of adenomyosis
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
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.
Interventions
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Transvaginal ultrasound
Transvaginal ultrasonographic scan aims to evaluate number, size (diameter and volume), location and appearance of submucous uterine myomas, concomitant presence of adenomyosis
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
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Ospedale Policlinico San Martino
OTHER
Responsible Party
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Fabio Barra
Principal Investigator
Locations
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IRCCS Ospedale Policlinico San Martino
Genoa, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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NOM-MYOMA RES
Identifier Type: -
Identifier Source: org_study_id
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