NCT05505656

Accuracy of Endomyometrial Biopsy in Diagnosis of Adenomyosis

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Adenomyosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	hysteroscopic guided endomyometrial biopsy	we will obtain hysteroscopic guided endomyometrial biopsy in cases of adenomyosis

Timeline

• Start date: 2022-06-09
• Primary completion: 2024-07-09
• Completion: 2024-07-09
• First posted: 2022-08-18
• Last updated: 2024-10-10

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated device study