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Clinical Trials/NCT05505656
NCT05505656
Completed
Not Applicable

Accuracy of Endomyometrial Biopsy in Diagnosis of Adenomyosis. A Prospective Cross-sectional Study

Ain Shams University1 site in 1 country70 target enrollmentJune 9, 2022
ConditionsAdenomyosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adenomyosis
Sponsor
Ain Shams University
Enrollment
70
Locations
1
Primary Endpoint
To compare endomyometrial biopsy with postoperative pathology to calculate Accuracy and likelihood ratio of endomyometrial biopsy to diagnose adenomyosis .
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study will compare the accuracy of diagnosing adenomyosis by obtaining hysteroscopic guided endomyometrial biopsy and comparing it to accuracy of diagnosis by transvaginal ultrasound and magnetic resonance imaging.

Detailed Description

Preoperative diagnosis of adenomyosis is usually difficult. The use of ultrasound and MRI for preoperative diagnosis is still of low positive predictive values. The majority of cases of adenomyosis are diagnosed postoperatively after justo pathological examination of the hysterectomy specimens. The introduction of the concept of preoperative diagnosis of adenomyosis through a hysteroscopic endomyometrial biopsies may be a very good method for preoperative diagnosis of this condition. Participants patients who are diagnosed as adenomyosis by Ultrasound and MRI and scheduled for hysterectomy will undergo an endomyometrial biopsy. The accuracy of this method, its sensitivity, specificity, positive and negative predictive values of this method will be compared with the conventional methods for preoperative diagnosis of adenomyosis after final diagnosis by final gusto pathological diagnosis of hysterectomy specimens.

Registry
clinicaltrials.gov
Start Date
June 9, 2022
End Date
July 9, 2024
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

dr mohamed laban

Professor of Obstetrics and Gynecology

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • patients diagnosed with abnormal uterine bleeding due to adenomyosis diagnosed by transvaginal ultrasound and mri and scheduled for hysterectomy

Exclusion Criteria

  • hysterectomy not performed
  • incomplete ultrasound and mri information

Outcomes

Primary Outcomes

To compare endomyometrial biopsy with postoperative pathology to calculate Accuracy and likelihood ratio of endomyometrial biopsy to diagnose adenomyosis .

Time Frame: through study completion, an average of 1 year

Secondary Outcomes

  • Sensitivity, specificity, positive and negative predictive values of endomyometrial biopsy for diagnosis of adenomyosis compared to US and MRI(through study completion, an average of 1 year)

Study Sites (1)

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