Acceptability and Tolerance of Hysteroscopy and Hysterosonography in Consultation

Study Overview
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Brief Summary
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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.

Official Title
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Acceptability and Tolerance of Hysteroscopy and Hysterosonography in Consultation

Conditions
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Metrorrhagia

Intervention / Treatment
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* Device: Hysteroscopy
* Device: Hysterosonography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hysteroscopy<br>Women with ≥ 18 with abnormal bleeding (post-menopausal menorrhagia or metrorrhagia), managed at bleeding clinic. Each women will undergo an hysteroscopy and a hysterosonography and will be her own control. | Device: Hysteroscopy<br>* Hysteroscopy allows a direct visualization of the interior of the uterine cavity in order to invalidate or confirm the presence of uterine pathologies.In the pre-menopausal period, it is preferable to perform a hysteroscopy at the beginning of the follicular phase (just after the menstruations, when the endometrium is atrophic). Use of a rigid hysteroscope comprising a 2.9 mm optics and a 4.3 mm sheath with a 5 - bit operator channel allowing the realization of a biopsy.<br>|
| Experimental: Hysterosonography<br>Women with ≥ 18 with abnormal bleeding (post-menopausal menorrhagia or metrorrhagia), managed at bleeding clinic. Each women will undergo an hysteroscopy and a hysterosonography and will be her own control. | Device: Hysterosonography<br>* Hysterosonography (SIS) is an endovaginal ultrasound performed along with an injection of saline in order to observe the uterine cavity and detect any endometrial pathology. A 3D image can be associated with it to define the topography of a lesion. It is ideally performed in the first part of the cycle. Use of the GE Voluson E8 Ultrasound System.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EVA pain scale | Visual analogic pain scale. It is a graduated horizontal or vertical scale of 10 cm with 2 marks: 0 for the complete absence of pain and 10 for the worst lived pain. | Baseline: before the examination | 
| EVA pain scale | Visual analogic pain scale. It is a graduated horizontal or vertical scale of 10 cm with 2 marks: 0 for the complete absence of pain and 10 for the worst lived pain. | 1 minute after the examination | 
| EVA pain scale | Visual analogic pain scale. It is a graduated horizontal or vertical scale of 10 cm with 2 marks: 0 for the complete absence of pain and 10 for the worst lived pain. | 5 minutes after the examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of side effects | Number of side effects for each technique | 2 days | 
| Patient tolerance | Patients will be asked at the end of the consultation if they would be ready to repeat the experiment or if they would have preferred to have the examination under general anesthesia. | 2 days | 
| Histological diagnose performance of each technique | Histological diagnostic performance (sensitivity and specificity) of each technique (biopsies) | 2 days | 
| Examination duration | Comparison of the duration of the two techniques | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hysteroscopy, Saline infusion hysterosonography