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Status unknownNCT04400942Updated Mar 4, 2021

Predictive Factors for Complete Myoma Resection During Hysteroscopic Myomectomy

An observational study in Uterine Fibroids and Uterine Myomas, sponsored by Ospedale Policlinico San Martino. Status unknown at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-04.

Sponsored by Ospedale Policlinico San Martino · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
600
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Uterine Fibroids
  • Uterine Myomas
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Patients with trasonographic diagnosis of uterine myomas undergoing hysteroscopic myomectomy

Inclusion criteria

  • patients with ultrasonographic diagnosis of uterine myomas

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
600 participants (estimated)
Patient registry
No

Groups and cohorts

  • Women with uterine myomas undergoing hysteroscopic myomectomy

    Diagnostic Test: Transvaginal ultrasound · Behavioral: Anamnesis · Procedure: Operative hysteroscopy

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

  • ProcedureOperative 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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What researchers measure

Primary outcomes

  1. Number of patients with complete resection of myomas

    Time frame: At the end of the hysteroscopic procedure

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Study locations

1 of 1 sites recruiting
  • IRCCS Ospedale Policlinico San Martino
    Genoa, 16132, Italy
    Recruiting
07

References and documents

Publications

  • 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. PubMed 27939896 ↗
  • 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. PubMed 27678974 ↗
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Registry details

Key details

Study ID
NCT04400942
Lead sponsor
Ospedale Policlinico San Martino
Responsible party
Fabio Barra (Principal Investigator, Ospedale Policlinico San Martino) — Principal investigator
First posted
May 26, 2020
Start date
Jan 1, 2015
Primary completion
Dec 1, 2021 (estimated)
Completion
Dec 1, 2021 (estimated)
Last update
Mar 4, 2021

Study contacts

Simone Ferrero, MD, PhD
Contact
simone.ferrero@unige.it
0039010511525

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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