- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03860909
Pelvic Endometriosis: Correlation of US and MRI With Laparoscopic Findings
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
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Amal y Abd ellah, MIS
- Phone Number: 01068440071
- Email: amlyusef123@gmail.com
Study Contact Backup
- Name: Reham A Abdel-Aleem, MD
- Phone Number: 01006464101
- Email: rehamali79@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Publications and helpful links
General Publications
- Abrao MS, Goncalves MO, Dias JA Jr, Podgaec S, Chamie LP, Blasbalg R. Comparison between clinical examination, transvaginal sonography and magnetic resonance imaging for the diagnosis of deep endometriosis. Hum Reprod. 2007 Dec;22(12):3092-7. doi: 10.1093/humrep/dem187. Epub 2007 Oct 18.
- Anaf V, Simon P, El Nakadi I, Fayt I, Buxant F, Simonart T, Peny MO, Noel JC. Relationship between endometriotic foci and nerves in rectovaginal endometriotic nodules. Hum Reprod. 2000 Aug;15(8):1744-50. doi: 10.1093/humrep/15.8.1744.
- Bazot M, Malzy P, Cortez A, Roseau G, Amouyal P, Darai E. Accuracy of transvaginal sonography and rectal endoscopic sonography in the diagnosis of deep infiltrating endometriosis. Ultrasound Obstet Gynecol. 2007 Dec;30(7):994-1001. doi: 10.1002/uog.4070.
- Ros C, Martinez-Serrano MJ, Rius M, Abrao MS, Munros J, Martinez-Zamora MA, Gracia M, Carmona F. Bowel Preparation Improves the Accuracy of Transvaginal Ultrasound in the Diagnosis of Rectosigmoid Deep Infiltrating Endometriosis: A Prospective Study. J Minim Invasive Gynecol. 2017 Nov-Dec;24(7):1145-1151. doi: 10.1016/j.jmig.2017.06.024. Epub 2017 Jun 30.
- Zhang JL. Functional Magnetic Resonance Imaging of the Kidneys-With and Without Gadolinium-Based Contrast. Adv Chronic Kidney Dis. 2017 May;24(3):162-168. doi: 10.1053/j.ackd.2017.03.006.
- Whittaker CS, Coady A, Culver L, Rustin G, Padwick M, Padhani AR. Diffusion-weighted MR imaging of female pelvic tumors: a pictorial review. Radiographics. 2009 May-Jun;29(3):759-74; discussion 774-8. doi: 10.1148/rg.293085130.
- Marcal L, Nothaft MA, Coelho F, Choi H. Deep pelvic endometriosis: MR imaging. Abdom Imaging. 2010 Dec;35(6):708-15. doi: 10.1007/s00261-010-9611-y.
- Koninckx PR, Martin D. Treatment of deeply infiltrating endometriosis. Curr Opin Obstet Gynecol. 1994 Jun;6(3):231-41.
- Mais V, Guerriero S, Ajossa S, Angiolucci M, Paoletti AM, Melis GB. The efficiency of transvaginal ultrasonography in the diagnosis of endometrioma. Fertil Steril. 1993 Nov;60(5):776-80. doi: 10.1016/s0015-0282(16)56275-x.
- Guerriero S, Mais V, Ajossa S, Paoletti AM, Angiolucci M, Labate F, Melis GB. The role of endovaginal ultrasound in differentiating endometriomas from other ovarian cysts. Clin Exp Obstet Gynecol. 1995;22(1):20-2.
- Fedele L, Bianchi S, Raffaelli R, Portuese A. Pre-operative assessment of bladder endometriosis. Hum Reprod. 1997 Nov;12(11):2519-22. doi: 10.1093/humrep/12.11.2519.
- Roseau G, Dumontier I, Palazzo L, Chapron C, Dousset B, Chaussade S, Dubuisson JB, Couturier D. Rectosigmoid endometriosis: endoscopic ultrasound features and clinical implications. Endoscopy. 2000 Jul;32(7):525-30. doi: 10.1055/s-2000-9008.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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