Pelvic Endometriosis: Correlation of US and MRI With Laparoscopic Findings

February 28, 2019 updated by: Amal yusef, Assiut University

Assessment of Pelvic Endometriosis: Correlation of US and MRI With Laparoscopic Findings

Endometriosis is classically defined as the presence of endometrial glands and stroma outside the uterine cavity and its musculature.

The definition of deep endometriosis is based on anatomic assumptions that may prove erroneous.

In fact, the term '' deep endometriosis '' should be reserved for lesions in the retroperitoneal tissue. For practical purposes, several reports included in the so-called deep endometriosis the infiltrative forms that involve vital structures such as the bowel, ureters, and bladder, as well as forms such as many rectovaginal lesions. For the term ''deep'' to apply, there should be ectopic endometrial tissue penetrating the peritoneum more than 5 mm in depth.

The ectopic endometrium responds to hormonal stimulation with various degrees of cyclic hemorrhage which result in suggestive symptoms and appearances.

A common symptom is infertility. Pelvic pain is a frequent complaint among patients with endometriosis. Such pain generally manifests as secondary dysmenorrhea, worsening primary dysmenorrhea, dyspareunia, or even noncyclic lower abdominal pain and backaches. The pain may be site-specific when endometriosis is found in unusual locations outside the pelvis.

Diagnosis Physical examination and laparoscopic exploration may not allow diagnosis or prediction of the extension of deep pelvic endometriosis, especially in pelvic retroperitoneal sites.

Transvaginal sonography is recommended for diagnosis of endometriomas and endometriosis of the bladder but its value for assessment of superficial peritoneal lesions, ovarian foci, and deep pelvic endometriosis is uncertain.

MR imaging is now commonly used for diagnosis of endometriosis and provides a tremendous advantage over other methods of investigation, owing to the possibility of making a complete survey of the anterior and posterior compartments of the pelvis at one time.

MRI is becoming a mainstay of preoperative diagnosis, in particular for diagnosis deep infiltrating endometriosis.

Study Overview

Status

Unknown

Conditions

Detailed Description

A prospective study including 30 Female patients of reproductive who were previously clinically diagnosed to have endometriotic lesions. these will be sent to our department to identify the extent of the lesions and clarify the exact location for proper treatment.

All patients were evaluated with ultrasound and MRI. the sensitivity, specificity and diagnostic accuracy for both examination were calculated.

Transvaginal ultrasound and MRI will be done in our Radiology department to all patients after signing an informed consent to be enrolled in the study.

All our imaging results were finally compared to the laparoscopic results which are our gold standard.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

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

Study Contact

Study Contact Backup

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

females with endometriosis

Description

Inclusion Criteria:

  • Female patients who have symptoms consistent with endometriosis such as pelvic pain, dysmenorrhea, deep dyspareunia, and infertility

Exclusion Criteria:

  • The common contraindication to MRI, peacemaker, metallic foreign bodies, and claustrophobia

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Mri with Us in correlation with laparoscopic findings in female patients with endometriosis
Time Frame: one year
comparison between MRI imaging and ultrasound combined with laproscopy in diagnosis of endometriosis
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The additive value of Mri in diagnosis of endometriosis
Time Frame: one year
MRI better than ultrasound in diagnosis of endometriosis in correlated with laproscopy
one year

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

February 27, 2019

First Submitted That Met QC Criteria

February 28, 2019

First Posted (Actual)

March 4, 2019

Study Record Updates

Last Update Posted (Actual)

March 4, 2019

Last Update Submitted That Met QC Criteria

February 28, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AssiutU10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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