NCT03860909

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

March 4, 2019

Status Verified

February 1, 2019

Enrollment Period

1 year

First QC Date

February 27, 2019

Last Update Submit

February 28, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The additive value of Mri in diagnosis of endometriosis

    one year

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

females with endometriosis

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • 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.

    PMID: 17947378BACKGROUND
  • 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.

    PMID: 10920097BACKGROUND
  • 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.

    PMID: 17992706BACKGROUND
  • 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.

    PMID: 28673872BACKGROUND
  • 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.

    PMID: 28501079BACKGROUND
  • 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.

    PMID: 19448114BACKGROUND
  • 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.

    PMID: 20390267BACKGROUND
  • Koninckx PR, Martin D. Treatment of deeply infiltrating endometriosis. Curr Opin Obstet Gynecol. 1994 Jun;6(3):231-41.

    PMID: 8038409BACKGROUND
  • 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.

    PMID: 8224260BACKGROUND
  • 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.

    PMID: 7736636BACKGROUND
  • 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.

    PMID: 9436698BACKGROUND
  • 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.

    PMID: 10917184BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Amal y Abd ellah, MIS

CONTACT

Reham A Abdel-Aleem, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

February 27, 2019

First Posted

March 4, 2019

Study Start

January 1, 2020

Primary Completion

January 1, 2021

Study Completion

May 1, 2021

Last Updated

March 4, 2019

Record last verified: 2019-02