RecruitingNCT04990076

Ultrasound Evaluation of the Myometrium Using the MUSA Terminology Comparison With Histology

Ultrasound Evaluation of the Myometrium Using the MUSA Terminology, Comparison With Histology.


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

1,500 participants

Start Date

Mar 11, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

The main objective is to evaluate the diagnostic accuracy of the MUSA terms and definitions, as defined in the paper by Van den Bosch T, Dueholm M, ea. in 2015, to differentiate between different types of myometrial lesions of more than 1 cm. The primary aim is the diagnostic accuracy of the MUSA terms and definitions and the secondary aim the development of a prediction model.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria1

  • Consecutive patients planned to undergo hysterectomy for myometrial pathology of more then 1cm (e.g. fibroid, focal adenomyosis, uterine sarcoma).

Exclusion Criteria7

  • Patient's refusal
  • Age \< 18 years
  • Polymyomatous uterus
  • Myometrial lesion with a diameter less then 10mm
  • Patients currently treated for another cancer
  • Patients with ovarian pathology, endometrial pathology of cervical pathology
  • Power morcellation

Interventions

PROCEDUREHysterectomy

Surgery includes different types of hysterectomy: vaginal hysterectomy, total abdominal hysterectomy and laparoscopic or Robotic hysterectomy. The type of hysterectomy does not influence histological outcome, as long as the uterus is removed in one part (no power morcellation). Indications for surgery and the type of surgery are according to the departments' protocols. If the patient is deemed to be inoperable due to the extent of the disease, a representive biopsy (e.g. trucut biopsy) will be accepted if sufficiently motivated by the oncology team.


Locations(1)

UZ Leuven

Leuven, Belgium

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NCT04990076


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