Metrorrhagia Clinical Trial
Official title:
Acceptability and Tolerance of Hysteroscopy and Hysterosonography in Consultation
Menorrhagia is frequent and occur in 11 to 13 % of the general population. It accounts for
20% of the gynecological consultations and tends to increase with age. It can be the first
symptom of a mild uterine disease or cancer (cervical or endometrial), especially if the
patient is older. The most common causes are polyps, adenomyosis, fibroids, hyperplasia and
cancer.
Menorrhagia needs to be investigated -especially after menopause, when the prevalence of
endometrial cancer is higher (10-15%). For premenopausal metrorrhagia, the assessment will be
made if a pathology is suspected or if there is no response to the medical treatment within 3
to 6 months.
The medical check-up consists in the first instance in a questionnaire, a clinical
examination and an endovaginal ultrasound examination. If the endometrium is thickened, a
focal pathology is suspected, or if the bleeding persists despite a normal endovaginal
ultrasound result, further examinations including a possible biopsy are required.
While hysteroscopy is widely accepted as a standard examination for uterine cavity
exploration, a meta-analysis showed that the diagnostic performance of hysterosonography was
equivalent. Both are carried out on an outpatient basis during a gynecological consultation
and require no special preparation. Several studies seem to show that hysterosonography is
less painful, causes less discomfort and is therefore more accepted by patients than
hysteroscopy. This is why many practitioners continue to prefer it to hysteroscopy and
associate it with the Pipelle of Cornier for the assessment of postmenopausal metrorrhagia.
However, if endometrial cancer is confirmed, the histological type detected within the biopsy
is the main predictor of the severity of the disease and the treatment to be given. It is
therefore essential to have an accurate biopsy sampling prior to therapeutic management. It
is not the case with blind biopsies (without visual control). Indeed, some studies showed
that the concordance between the optical aspect of the endometrium under hysteroscopy and the
histological result was close to 90%, validating the hypothesis of an improved sensitivity
through visual control.
The American College of Obstetricians and Gynecologists (ACOG) currently recommends an
endovaginal ultrasound assessment followed by an endometrial biopsy in the event of a
thickened endometrium or when a pathology is suspected. A biopsy can even be taken during the
consultation, at the onset of the complaints. The last recommendations of December 2010 leave
the choice to clinicians regarding the histological diagnostic modalities (a blind biopsy
with the Pipelle of Cornier or a targeted biopsy under hysteroscopy), although the biopsies
under hysteroscopy are recommended since 2015. However, despite its poor sensitivity, the
most widely used technique in the world is the blind biopsy by aspiration performed after
vaginal ultrasound or hysterosonography because it is an easy low cost method.
The development of hysteroscopes with a smaller diameter and the introduction of the
vaginoscopy have considerably increased the tolerance of this examination. In addition,
hysteroscopy allows a simultaneous therapeutic intervention for certain indications, which is
comfortable and well accepted by the patients. Unfortunately, there are few studies comparing
the tolerance of the two examinations performed according to the current recommendations of
good practice of hysteroscopy. Only one comparative randomized study in 2008 showed that
saline infusion sonography (SIS) was less painful than hysteroscopy with vaginoscopy.
However, direct comparison was impossible since women only had one of the two examinations.
The Brugmann University Hospital set up a consultation called "one stop bleeding clinic" in
which the two examinations are performed for each patient with abnormal bleedings, in order
to increase diagnostic performance.
All included patients will thus undergo a saline infusion sonography (SIS) and a hysteroscopy
(HSC). Each procedure will be evaluated on pain level (EVA scale) and tolerance by the
patient.
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