Measurement of Fibroid Volume and 2D, 3D US

December 22, 2015 updated by: Sherin A Shazly, Zagazig University

Uterine Fibroid Volume After Myomectomy Compared to Pre-operative Measurement by Two and Three-dimensional Ultrasound

Objective: To compare 2-dimensional and 3-dimensional ultrasound measurements with the actual myomas volume after surgical removal, to clinically test the validity and usability of 3D ultrasound technology as opposed to conventional 2D real-time ultrasound and to assess the reliability of different ultrasound methods to measure volume of uterine fibroids.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3

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

22 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

44

Description

Inclusion Criteria:

  • surgical intervention

Exclusion Criteria:

  • unfit for surgery

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
2D ultrasound
2D-US measurements are the most accurate method for measuring fibroid volumes
Other: ultrasound
3D ultrasound
3D-US measurements are the most accurate method for measuring fibroid volumes
Other: ultrasound
postoperative
actual volume using change in water path measurements are the most accurate method for measuring fibroid volumes
Other: ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
measuring fibroid volumes
Time Frame: 2012-2015
2012-2015

Collaborators and Investigators

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

Sponsor

Zagazig University

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

September 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

December 18, 2015

First Submitted That Met QC Criteria

December 22, 2015

First Posted (Estimate)

December 23, 2015

Study Record Updates

Last Update Posted (Estimate)

December 23, 2015

Last Update Submitted That Met QC Criteria

December 22, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s.shazly
  • 2011 (Registry Identifier: sherin)

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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