NCT04400942

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

6.9 years

First QC Date

May 19, 2020

Last Update Submit

March 3, 2021

Conditions

Uterine FibroidsUterine Myomas

Outcome Measures

Primary Outcomes (1)

  • Number of patients with complete resection of myomas

    At the end of the hysteroscopic procedure

Study Arms (1)

Women with uterine myomas undergoing hysteroscopic myomectomy

Diagnostic Test: Transvaginal ultrasoundBehavioral: AnamnesisProcedure: Operative hysteroscopy

Interventions

Transvaginal ultrasoundDIAGNOSTIC_TEST

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

Women with uterine myomas undergoing hysteroscopic myomectomy
AnamnesisBEHAVIORAL

Anamnesis aims to collect data about age, BMI, previous hormonal therapies (such as ulipristal acetate or gonadotropin-releasing hormone agonists) with submucous uterine myomas

Women with uterine myomas undergoing hysteroscopic myomectomy
Operative hysteroscopyPROCEDURE

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.

Women with uterine myomas undergoing hysteroscopic myomectomy

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with trasonographic diagnosis of uterine myomas undergoing hysteroscopic myomectomy

You may qualify if:

  • patients with ultrasonographic diagnosis of uterine myomas

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale Policlinico San Martino

Genoa, 16132, Italy

RECRUITING

Related Publications (2)

  • 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.

    PMID: 27939896BACKGROUND

  • 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.

    PMID: 27678974BACKGROUND

MeSH Terms

Conditions

Leiomyoma

Interventions

Immunologic Memory

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Adaptive ImmunityImmunityImmune System Phenomena

Central Study Contacts

Simone Ferrero, MD, PhD

CONTACT

0039010511525simone.ferrero@unige.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 26, 2020

Study Start

January 1, 2015

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

March 4, 2021

Record last verified: 2021-03

Locations

IT(1)