Clinical Trial: Acceptability and Tolerance of Hysteroscopy and Hysterosonography in Consultation

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Acceptability and Tolerance of Hysteroscopy and Hysterosonography in Consultation

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 sever

Detailed Summary:
Sponsor: Brugmann University Hospital

Current Primary Outcome:

• EVA pain scale [ Time Frame: Baseline: before the examination ]
  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.
• EVA pain scale [ Time Frame: 1 minute after the examination ]
  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.
• EVA pain scale [ Time Frame: 5 minutes after the examination ]
  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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Number of side effects [ Time Frame: 2 days ]
  Number of side effects for each technique
• Patient tolerance [ Time Frame: 2 days ]
  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.
• Histological diagnose performance of each technique [ Time Frame: 2 days ]
  Histological diagnostic performance (sensitivity and specificity) of each technique (biopsies)
• Examination duration [ Time Frame: 2 days ]
  Comparison of the duration of the two techniques

Original Secondary Outcome: Same as current

Information By: Brugmann University Hospital

Dates:
Date Received: April 14, 2017
Date Started: September 2017
Date Completion: December 2018
Last Updated: April 19, 2017
Last Verified: April 2017