Pelvic Endometriosis: Correlation of US and MRI With Laparoscopic Findings

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03860909
• Other study ID #: AssiutU10
• Status: Not yet recruiting
• Start date: January 2020
• Est. completion date: May 2021

Study information

• Verified date: February 2019
• Source: Assiut University
• Contact: Amal y Abd ellah, MIS
• Phone: 01068440071
• Email: amlyusef123[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (12)

Abrao MS, Gonçalves 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. Epub 2007 Oct 18. — View Citation

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. — View Citation

Bazot M, Malzy P, Cortez A, Roseau G, Amouyal P, Daraï 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. — View Citation

Fedele L, Bianchi S, Raffaelli R, Portuese A. Pre-operative assessment of bladder endometriosis. Hum Reprod. 1997 Nov;12(11):2519-22. — View Citation

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. — View Citation

Koninckx PR, Martin D. Treatment of deeply infiltrating endometriosis. Curr Opin Obstet Gynecol. 1994 Jun;6(3):231-41. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Ros C, Martínez-Serrano MJ, Rius M, Abrao MS, Munrós J, Martínez-Zamora MÁ, 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Mri with Us in correlation with laparoscopic findings in female patients with endometriosis	comparison between MRI imaging and ultrasound combined with laproscopy in diagnosis of endometriosis	one year
Secondary	The additive value of Mri in diagnosis of endometriosis	MRI better than ultrasound in diagnosis of endometriosis in correlated with laproscopy	one year