Accuracy of Endomyometrial Biopsy in Diagnosis of Adenomyosis

• Sponsor: Ain Shams University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05505656
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adenomyosis	Diagnostic Test: hysteroscopic guided endomyometrial biopsy

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 Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Accuracy of Endomyometrial Biopsy in Diagnosis of Adenomyosis. A Prospective Cross-sectional Study
• Actual Study Start Date: Jun 9, 2022
• Anticipated Primary Completion Date: Jun 9, 2023
• Anticipated Study Completion Date: Jun 9, 2023

Outcome Measures

Primary Outcome Measures

1. 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

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University Maternity Hospital	Cairo		Egypt

Sponsors and Collaborators

• Ain Shams University

Investigators

• Principal Investigator: Mohamed Laban, Professor of Obstetrics and Gynecology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: dr mohamed laban, Professor of Obstetrics and Gynecology, Ain Shams University
• ClinicalTrials.gov Identifier: NCT05505656
• Other Study ID Numbers: MD 129/ 2022
• First Posted: Aug 18, 2022
• Last Update Posted: Aug 18, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Adenomyosis

Study Results

No Results Posted as of Aug 18, 2022