The aim of the study is to optimize the MRI sequences in order to detect superficial endometriosis with high sensitivity and study the preliminary accuracy of an optimized MRI protocol in the detection of superficial lesions related to endometriosis…
ID
Source
Brief title
Condition
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective: to study the preliminary accuracy of an optimized MRI
protocol in the detection of superficial lesions related to endometriosis.
Secondary outcome
na
Background summary
Surgical excision of endometriosis is an effective treatment for
endometriosis-associated subfertility. Surgical intervention improves the rate
of spontaneous pregnancy mainly for stage I and II endometriosis.
If women have a regular cycle, a partner with a normal sperm examination, and
if they have been unsuccessful in trying to conceive for more than 1 year
without moderate to severe cyclic or chronic pelvic pain (requiring at least
cyclic or chronic use of pain killers), combined with a normal clinical
examination and a normal pelvic ultrasound, most gynecologists are not sure if
endometriosis is present and if it is useful to do a diagnostic laparoscopy.
From a clinical perspective, they may have extensive peritoneal endometriosis
with or without adhesions associated with subfertility and possibly mild pain.
For this population, a noninvasive diagnostic test would be useful to rule in
those with endometriosis, most likely minimal to mild disease, who are known to
benefit from surgical therapy for both subfertility and pain. However, none of
the known test are sufficcient sensitive in order to miss no women with
endometriosis.
Study objective
The aim of the study is to optimize the MRI sequences in order to detect
superficial endometriosis with high sensitivity and study the preliminary
accuracy of an optimized MRI protocol in the detection of superficial lesions
related to endometriosis.
Study design
A female group patients with clinical suspicion of endometriosis MRI will be
performed. Only patients who will undergo laparascopy for the diagnosis or
therapy of the endometriosis in the clinical set-up will be retrieved.
Study burden and risks
MRI is for as far as known not dangerous. Patients have to stay for around
30-45 minutes in a small bore, and patients who are claustrofobic can object to
participate. MRI-scanning is relatively noiseful and for that reason earplugs
are given. Since the MRI induces magnetic fields patients with a pacemaker or
some metallic parts are refused to participed. Buscopan will be injected
intravenously in all patients except for those who have glaucoma or cardiac
dysrythmiae.
Dr. Molewaterplein 40
3015 GD
Nederland
Dr. Molewaterplein 40
3015 GD
Nederland
Listed location countries
Age
Inclusion criteria
-18-35 years old
-female
-signed informed consent
Exclusion criteria
-contra-indications for laparoscopy
-contra-indications for MRI
-use of agents that suppressing the hormonal state (e.g. GnRH analogues)
-glaucoma
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL21879.078.08 |