Accuracy of Endomyometrial Biopsy in Diagnosis of Adenomyosis

Adenomyosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05505656
• Other study ID #: MD 129/ 2022
• Status: Recruiting
• Start date: June 9, 2022
• Est. completion date: June 9, 2023

Study information

• Verified date: August 2022
• Source: Ain Shams University
• Contact: Mohamed Laban
• Phone: 0201004273
• Email: laban63[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 9, 2023
• Est. primary completion date: June 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomyosis

Intervention

Diagnostic Test:
• hysteroscopic guided endomyometrial biopsy
we will obtain hysteroscopic guided endomyometrial biopsy in cases of adenomyosis

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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