Accuracy of Endomyometrial Biopsy in Diagnosis of Adenomyosis

Completed

• Conditions: Adenomyosis

• Registration Number: NCT05505656
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2022-06-09
• Study First Submitted: 2022-08-14
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-18
• Primary Completion: 2024-07-09
• Study Completion: 2024-07-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare endomyometrial biopsy with postoperative pathology to calculate Accuracy and likelihood ratio of endomyometrial biopsy to diagnose adenomyosis .	through study completion, an average of 1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ain Shams University Maternity Hospital; 🇪🇬 Cairo, Egypt