Clinical trial NCT03121560: Acceptability and Tolerance of Hysteroscopy and Hysterosonography in Consultation
Official title: Acceptability and Tolerance of Hysteroscopy and Hysterosonography in Consultation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metrorrhagia
Keywords: Hysteroscopy
Saline infusion hysterosonography
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective cross-over study (each woman will be her own control) on women with peri-menopausal menorrhagia. Each woman, after signing the informed consent, will come into the "bleeding clinic" where she will undergo both examinations in a random order, in two days time.
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Women with abnormal bleedings (post-menopausal menorrhagia or metrorrhagia managed at bleeding clinic) without endometrial measurement criteria.
* Level of French/Dutch sufficient to understand the informed consent document and the pain evaluation scale

Exclusion Criteria:

* Spontaneous intake of an analgesic before the examinations
* Women who already had an SIS or hysteroscopy

Primary outcomes:
measure: EVA pain scale
timeFrame: Baseline: before the examination
measure: EVA pain scale
timeFrame: 1 minute after the examination
measure: EVA pain scale
timeFrame: 5 minutes after the examination
Secondary outcomes:
measure: Number of side effects
timeFrame: 2 days
measure: Patient tolerance
timeFrame: 2 days
measure: Histological diagnose performance of each technique
timeFrame: 2 days
measure: Examination duration
timeFrame: 2 days
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: André Nazac, MD
role: PRINCIPAL_INVESTIGATOR
References: