To determine whether cine-MRI is able to assess the so-called *sliding viscera* sign in the posterior compartment, an known sonographic indicator for the absence of POD adhesions.
ID
Source
Brief title
Condition
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Detection of sliding viscera sign with cine-MRI.
Secondary outcome
n/a
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.
Study objective
To determine whether cine-MRI is able to assess the so-called *sliding viscera*
sign in the posterior compartment, an known sonographic indicator for the
absence of POD adhesions.
Study design
A prospective observational pilot study.
If this pilot study shows that cine-MRI is able to assess sliding viscera sign
in the posterior compartment, this modality will be added to the conventional
MRI protocol in a prospective study comparing the accuracy of MRI and
transvaginal ultrasound (TVUS) in predicting the extent of deep infiltrating
endometriosis.
Study burden and risks
All participants will undergo a transvaginal ultrasound and MRI. There is no
risk involved in participation, other than possible chance findings of
unrelated pathology.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Aged 18-45 years
Endometriosis patients:
- Known POD obliteration, diagnosed either by diagnostic laparoscopy or negative sliding viscera sign on transvaginal ultrasound
Control subjects:
- Positive sliding viscera sign on transvaginal ultrasound
Exclusion criteria
Any contra-indication for MRI (e.g. claustrophobia, non-MRI-compatible implanted devices, metal splinters in eye)
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-endometriosis adhesions.
- No transvaginal ultrasound performed
Control subjects:
- Known history of endometriosis, pelvic inflammatory disease, intra-abdominal adhesions or abdominal surgery other than diagnostic laparoscopy.
- Signs/symptoms of endometriosis, such as dysmenorrhea, dyspareunia, dyschezia or unexplained subfertility. This is not an exclusion criterion if endometriosis and adhesions have been previously ruled out by diagnostic laparoscopy.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63932.068.17 |
| OMON | NL-OMON29313 |