Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Histopathological Diagnosis of Adenomyosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02340533
Recruitment Status : Completed
First Posted : January 16, 2015
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Dina Mohamed Refaat Dakhly, 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.

Condition or disease Intervention/treatment Phase
Adenomyosis Procedure: hysteroscopic endo-myometrial biopsy Device: ultrasound Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: The Diagnostic Accuracy of Hysteroscopic Endomyometrial Biopsy in Adenomyosis
Study Start Date : January 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: 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.
Procedure: hysteroscopic endo-myometrial biopsy
Device: ultrasound
two dimensional trans-vaginal ultrasonography




Primary Outcome Measures :
  1. Number of participants with diagnosis of adenomyosis cases [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   38 Years to 52 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02340533


Locations
Layout table for location information
Egypt
Kasr el aini hospital
Cairo, Egypt, 12211
Sponsors and Collaborators
Woman's Health University Hospital, Egypt
Investigators
Layout table for investigator information
Principal Investigator: Dina M Dakhly, MD Cairo University

Layout table for additonal information
Responsible Party: Dina Mohamed Refaat Dakhly, lecturer of obstetrics and gynecology, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT02340533     History of Changes
Other Study ID Numbers: AD0152015
First Posted: January 16, 2015    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015

Keywords provided by Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt:
adenomyosis

Additional relevant MeSH terms:
Layout table for MeSH terms
Adenomyosis
Uterine Diseases
Genital Diseases, Female