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MetrorrhagiaNCT03121560

Acceptability and Tolerance of Hysteroscopy and Hysterosonography in Consultation

A study testing Hysteroscopy and Hysterosonography in people with Metrorrhagia, run by Brugmann University Hospital at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metrorrhagia
What is being tested?
Hysteroscopy and Hysterosonography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteBelgium
Study dates
14 Nov 2017to 25 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • CHU Brugmann

    Brussels, 1020

Other trials in Belgium

About this study

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.

Read more

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.

Conditions
Metrorrhagia
Being tested
Hysteroscopy, Hysterosonography
Keywords
Hysteroscopy, Saline infusion hysterosonography
Medical subject headings
Metrorrhagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HysteroscopyDevice

    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.

  • HysterosonographyDevice

    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.

Study groups in NCT03121560
Study groupRoleWhat they receive
HysteroscopyActive comparatorWomen 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.
Receives: Device: Hysteroscopy
HysterosonographyExperimentalWomen 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.
Receives: Device: Hysterosonography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline: before the examination

  2. 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.

    Measured: 1 minute after the examination

  3. 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.

    Measured: 5 minutes after the examination

Secondary outcomes (4)
  1. Number of side effects

    Number of side effects for each technique

    Measured: 2 days

  2. 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.

    Measured: 2 days

  3. Histological diagnose performance of each technique

    Histological diagnostic performance (sensitivity and specificity) of each technique (biopsies)

    Measured: 2 days

  4. Examination duration

    Comparison of the duration of the two techniques

    Measured: 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2017
  2. Study start14 Nov 2017
  3. Primary completion25 Jul 2019
  4. Study completion25 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
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)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03121560
Sponsor's protocol ID
CHUB-EVAdolHYSIS
Status last verified
Aug 2020
First submitted
14 Apr 2017
Last updated
7 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Hysteroscopy and Hysterosonography in people with Metrorrhagia, run by Brugmann University Hospital at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EVA pain scale (time frame: Baseline: before the examination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.

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