Histopathological Diagnosis of Adenomyosis

Not Applicable

Completed

• Conditions: Adenomyosis
• Interventions: Procedure: hysteroscopic endo-myometrial biopsy; Device: ultrasound

• Registration Number: NCT02340533
• Lead Sponsor: Woman's Health University Hospital, Egypt

Brief Summary

The purpose of this study is to develop and evaluate a hysteroscopic endo-myometrial biopsy for diagnosing adenomyosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-01-15
• Study First Posted: 2015-01-16
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-26
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• females complaining of pelvic congestion: dysmenorrhea, dyspareunia, chronic pelvic pain, menorrhagia, metrorrhagia

Exclusion Criteria

• refusal of the patient to get enrolled in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
adenomyosis	hysteroscopic endo-myometrial biopsy	females attending the gynecology outpatient clinic complaining of chronic pelvic congestion will get enrolled in the study. Two dimensional ultrasonography will be performed to asses the presence or absence of adenomyosis or any associated lesions. All the patients were then be subjected to office hysteroscopy and endo-myometrial biopsies will be taken. Histopathological examination of the samples will then be done. From these recruited patients, some will be indicated to perform hysterectomy. The final diagnosis will then be based on the histopathological examination of the specimen retrieved from hysterectomy. The accuracy of the ultrasound and the hysteroscopic endo-myometrial biopsy will then be compared and assessed.
adenomyosis	ultrasound	females attending the gynecology outpatient clinic complaining of chronic pelvic congestion will get enrolled in the study. Two dimensional ultrasonography will be performed to asses the presence or absence of adenomyosis or any associated lesions. All the patients were then be subjected to office hysteroscopy and endo-myometrial biopsies will be taken. Histopathological examination of the samples will then be done. From these recruited patients, some will be indicated to perform hysterectomy. The final diagnosis will then be based on the histopathological examination of the specimen retrieved from hysterectomy. The accuracy of the ultrasound and the hysteroscopic endo-myometrial biopsy will then be compared and assessed.

Primary Outcome Measures

Name	Time	Method
Number of participants with diagnosis of adenomyosis cases	6 months

Trial Locations

Locations (1)

Kasr el aini hospital; 🇪🇬 Cairo, Egypt