Vocal in Assessment of Endometrium in Postmenopause

October 1, 2018 updated by: Mahmoud Alalfy, Aljazeera Hospital

The Relation Between Endometrial Volume by 3D Vocal Ultrasound and Histopathology in Women With Postmenopausal Bleeding

The unbalanced estrogen with no progesterone will lead to endometrial thickening .This thickening result in endometrial hyperplasia & carcinoma and lead to irregular bleeding

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recent advances in the screening and diagnosis of endometrial pathologies (eg,endometrial hyperplasia , endometrial carcinoma ,endometrial polyps and myomas ) are directed towards non invasive methods as Transvaginal ultrasound with 3 D application using different softwares .

One of the applications of 3D Transvaginal Ultrasonography is Vocal technique ( Virtual Organ Computer aided Analysis ) that can measure volume especially in tissues with irregular borders And this technology is considered to be superior than the conventional 2 D ultrasound . .

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • Algazeerah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Postmenopausal women who were Complaining of Post-menopausal vaginal bleeding.

Description

Inclusion Criteria:

-Postmenopausal women who were Complaining of Post-menopausal vaginal bleeding.

Exclusion Criteria:

  • Women with hormone replacement therapy.
  • Women showing intra-cavitary fluid collection at ultrasound examination
  • Women with other gynecological lesions in the pelvis other than the uterus
  • Previous diagnosis of endometrial pathology.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of participants who where diagnosed by 3D vocal to have endometrial carcinoma
Time Frame: within 4 weeks
it describes how many women will be properly diagnosed with carcinoma
within 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aljazeera Hospital

Collaborators

Kasr El Aini Hospital
National Research Centre, Egypt
om almasreen hospital ,Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 18, 2018

Primary Completion (ACTUAL)

August 1, 2018

Study Completion (ACTUAL)

August 25, 2018

Study Registration Dates

First Submitted

January 12, 2018

First Submitted That Met QC Criteria

January 12, 2018

First Posted (ACTUAL)

January 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 2, 2018

Last Update Submitted That Met QC Criteria

October 1, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VOCAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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