No registrations found.
ID
Source
Health condition
Endometriosis, cine MRI, sliding viscera
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine whether cine-MRI is able to visualize the sliding viscera sign in the posterior compartment in healthy subjects and if the cine-MRI is able to show a reduction in the visceral slide in patients with proven adhesions.
Secondary outcome
Establishing a cine-MRI technique with optimal sequences and non-invasive movements of the patient to adequately induce the visceral slide sign.
Background summary
The decision to perform surgery in patients with deep endometriosis is largely based on the suspected extent of the disease and subsequent risk of complications. This risk increases greatly when adhesions obliterate the pouch of Douglas (POD). Magnetic resonance imaging (MRI) is widely regarded as a reliable diagnostic tool in presurgical assessment of endometriosis, but the static nature of conventional MRI makes it an inferior test for detecting intra-abdominal adhesions. Functional cine-MRI has proven to be a promising imaging technique for the identification of intra-abdominal adhesions in patients with acute or chronic pain.
The objective of this study is to determine whether cine-MRI is able to assess the so-called ‘sliding viscera’ sign in the posterior compartment, a known sonographic indicator for the absence of POD adhesions.
Women without symptoms or a history of endometriosis will undergo a structured transvaginal ultrasound (TVUS) by a trained sonographer to establish that the sliding viscera sign is positive, i.e. there are no POD adhesions detectable on ultrasound. Participants will then undergo a cine MRI where images are made using different patient instructions. A protocol is developed for the optimal detection of sliding viscera sign with cine-MRI, which is then tested in women with endometriosis and proven POD adhesions.
Study objective
Cine-MRI is able to detect adhesions in the pouch of Douglas in endometriosis patients by visualizing the presence or absence of the sliding viscera sign.
Study design
Evaluation is done by one of the radiologists participating in the study directly following MRI.
Intervention
The use of cineMRI in addition to standard MRI and transvaginal ultrasound for endometriosis in the evaluation of POD visceral slide.
R.R.M. Vogels
P.O. Box 5800
Maastricht 6202 AZ
The Netherlands
0612644007
endometriose.mri@gmail.com
R.R.M. Vogels
P.O. Box 5800
Maastricht 6202 AZ
The Netherlands
0612644007
endometriose.mri@gmail.com
Inclusion criteria
- Female aged 18-45 years
- control subjects: positive sliding viscera sign on transvaginal ultrasound.
- Endometriosis patients: known POD obliteration diagnosed either by diagnostic laparoscopy or negative sliding viscera on TVUS.
Exclusion criteria
- Any contra-indication for MRI
- patient does not want to be informed about potential incidental findings on MRI
endometriosis patients:
-prior adhesiolysis of POD adhesions
- history of abdominal surgery (other than diagnostic laparoscopy) as this increases the risk of non-endometrious adhesions
- no transvaginal ultrasound
Control subjects:
- known history of endometriosis, PID, intra-abdominal adhesions or abdominal surgery other than diagnostic laparoscopy
- signs/symptoms of endometriosis, such as dysmenorrhea, dyspareunia, dyschezia or unexplained subfertility
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6862 |
| NTR-old | NTR7040 |
| CCMO | NL63932.068.17 |
| OMON | NL-OMON46426 |