Histopathological Diagnosis of Adenomyosis

NCT ID: NCT02340533

Last Updated: 2015-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-06-30

Brief Summary

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

Detailed Description

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Conditions

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Adenomyosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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adenomyosis

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.

Group Type EXPERIMENTAL

hysteroscopic endo-myometrial biopsy

Intervention Type PROCEDURE

ultrasound

Intervention Type DEVICE

two dimensional trans-vaginal ultrasonography

Interventions

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hysteroscopic endo-myometrial biopsy

Intervention Type PROCEDURE

ultrasound

two dimensional trans-vaginal ultrasonography

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

38 Years

Maximum Eligible Age

52 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Woman's Health University Hospital, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Dina Mohamed Refaat Dakhly

lecturer of obstetrics and gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dina M Dakhly, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Kasr el aini hospital

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AD0152015

Identifier Type: -

Identifier Source: org_study_id

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