EndometriosisNCT03860909
Pelvic Endometriosis: Correlation of US and MRI With Laparoscopic Findings
An observational study of Endometriosis, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: females with endometriosis
Who may be able to join
- Female patients who have symptoms consistent with endometriosis such as pelvic pain, dysmenorrhea, deep dyspareunia, and infertility
Who cannot join
- The common contraindication to MRI, peacemaker, metallic foreign bodies, and claustrophobia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Endometriosis
- Medical subject headings
- Endometriosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (1)
The additive value of Mri in diagnosis of endometriosis
MRI better than ultrasound in diagnosis of endometriosis in correlated with laproscopy
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study startJan 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal yusef, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860909
- Sponsor's protocol ID
- AssiutU10
- Status last verified
- Feb 2019
- First submitted
- 27 Feb 2019
- Last updated
- 4 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 17947378Anaf 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.
PubMed 10920097Bazot 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.
PubMed 17992706Ros 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.
PubMed 28673872Zhang 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.
PubMed 28501079Whittaker 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.
PubMed 19448114Marcal 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.
PubMed 20390267Koninckx PR, Martin D. Treatment of deeply infiltrating endometriosis. Curr Opin Obstet Gynecol. 1994 Jun;6(3):231-41.
PubMed 8038409Mais 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.
PubMed 8224260Guerriero 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.
PubMed 7736636Fedele 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.
PubMed 9436698Roseau 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.
PubMed 10917184
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pelvic Endometriosis: Correlation of US and MRI With Laparoscopic Findings
- ClinicalTrials.gov ID
- NCT03860909
- Acronym / sponsor ID
- AssiutU10
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- females with endometriosis
Key inclusion criteria (1 listed)
- Female patients who have symptoms consistent with endometriosis such as pelvic pain, dysmenorrhea, deep dyspareunia, and infertility
Key exclusion criteria (1 listed)
- The common contraindication to MRI, peacemaker, metallic foreign bodies, and claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
The additive value of Mri in diagnosis of endometriosis
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Background: PubMed 17947378Abrao 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.
- Background: PubMed 10920097Anaf 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.
- Background: PubMed 17992706Bazot 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.
- Background: PubMed 28673872Ros 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.
- Background: PubMed 28501079Zhang 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.
- Background: PubMed 19448114Whittaker 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.
- Background: PubMed 20390267Marcal 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.
- Background: PubMed 8038409Koninckx PR, Martin D. Treatment of deeply infiltrating endometriosis. Curr Opin Obstet Gynecol. 1994 Jun;6(3):231-41.
- Background: PubMed 8224260Mais 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.
- Background: PubMed 7736636Guerriero 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.
- Background: PubMed 9436698Fedele 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.
- Background: PubMed 10917184Roseau 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amal y Abd ellah, MIS (01068440071, amlyusef123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Mri with Us in correlation with laparoscopic findings in female patients with endometriosis (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03860909, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2019; AzTrials last refreshed its copy on 8 Nov 2026.