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Predictive Factors for Complete Myoma Resection During Hysteroscopic Myomectomy

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04400942
Enrollment
600
Registered
2020-05-26
Start date
2015-01-01
Completion date
2021-12-01
Last updated
2021-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Fibroids, Uterine Myomas

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.

Interventions

DIAGNOSTIC_TESTTransvaginal ultrasound

Transvaginal ultrasonographic scan aims to evaluate number, size (diameter and volume), location and appearance of submucous uterine myomas, concomitant presence of adenomyosis

BEHAVIORALAnamnesis

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 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.

Sponsors

Ospedale Policlinico San Martino
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frame
Number of patients with complete resection of myomasAt the end of the hysteroscopic procedure

Countries

Italy

Contacts

Primary ContactSimone Ferrero, MD, PhD
simone.ferrero@unige.it0039010511525

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026