Histopathological Diagnosis of Adenomyosis

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

hysteroscopic endo-myometrial biopsy

ultrasound

About this trial

This is an interventional diagnostic trial for Adenomyosis focused on measuring adenomyosis

Eligibility Criteria

38 Years - 52 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Kasr el aini hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

adenomyosis

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of participants with diagnosis of adenomyosis cases

Secondary Outcome Measures

Full Information

NCT ID

NCT02340533

First Posted

January 9, 2015

Last Updated

July 26, 2015

Sponsor

Woman's Health University Hospital, Egypt

1. Study Identification

Unique Protocol Identification Number

NCT02340533

Brief Title

Histopathological Diagnosis of Adenomyosis

Official Title

The Diagnostic Accuracy of Hysteroscopic Endomyometrial Biopsy in Adenomyosis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Woman's Health University Hospital, Egypt

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenomyosis

Keywords

adenomyosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

adenomyosis

Arm Type

Experimental

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

hysteroscopic endo-myometrial biopsy

Intervention Type

Device

Intervention Name(s)

ultrasound

Intervention Description

two dimensional trans-vaginal ultrasonography

Primary Outcome Measure Information:

Title

Number of participants with diagnosis of adenomyosis cases

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

38 Years

Maximum Age & Unit of Time

52 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dina M Dakhly, MD

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kasr el aini hospital

City

Cairo

ZIP/Postal Code

12211

Country

Egypt

Adenomyosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial