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.
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
- Type of treatment
- Injection or infusion, Medical device
- 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.
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 group | Role | What they receive |
|---|---|---|
| Hysteroscopy | Active comparator | 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. Receives: Device: Hysteroscopy |
| Hysterosonography | Experimental | 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. Receives: Device: Hysterosonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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)
Number of side effects
Number of side effects for each technique
Measured: 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.
Measured: 2 days
Histological diagnose performance of each technique
Histological diagnostic performance (sensitivity and specificity) of each technique (biopsies)
Measured: 2 days
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.
- First posted20 Apr 2017
- Study start14 Nov 2017
- Primary completion25 Jul 2019
- Study completion25 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetrorrhagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Nazac, Brugmann University Hospital
- Investigators
- André Nazac, MD, Principal investigator, CHU Brugmann
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Tolerance of Hysteroscopy and Hysterosonography in Consultation
- ClinicalTrials.gov ID
- NCT03121560
- Acronym / sponsor ID
- CHUB-EVAdolHYSIS
- Conditions
- Metrorrhagia
- Keywords
- Hysteroscopy, Saline infusion hysterosonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 25 Jul 2019 (actual)
- Study completion
- 25 Jul 2019 (actual)
- First posted
- 20 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hysteroscopy | Active comparator | Device: HysteroscopyWomen 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. |
| Hysterosonography | Experimental | Device: HysterosonographyWomen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Spontaneous intake of an analgesic before the examinations
- Women who already had an SIS or hysteroscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HysteroscopyHysteroscopy 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. | Device | Hysteroscopy |
| HysterosonographyHysterosonography (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. | Device | Hysterosonography |
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.
4 secondary outcomes
Number of side effects
Time frame: 2 days
Patient tolerance
Time frame: 2 days
Histological diagnose performance of each technique
Time frame: 2 days
Examination duration
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
André Nazac, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
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.