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All women presenting to the gynaecology outpatient clinic with heavy menstrual bleeding (HMB) in the absence of recognizable pelvic pathology, as determined by one or all of a normal pelvic ultrasound, hysteroscopy and / or endometrial biopsy, refractory to medical therapy that persists despite treatment with recommended pharmacological agents(1,2), who have no desire to preserve their fertility and are willing to have an endometrial ablation will be invited to participate. Eligible women with HMB will undergo radiofrequency G4 endometrial ablation in either an inpatient or outpatient setting according to their preference.
Outcomes will be assessed by administering postal questionnaires to measure menstrual bleeding symptoms including rates of amenorrhoea, dysmenorrhoea and life quality at baseline and at 6, and 12 months after ablative treatment. After the main study, there will be an additional evaluation of the long-term effects of outpatient ablative treatments of the endometrium by postal survey at 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endometrial Ablation (4th gen) | Experimental | A single-centre uncontrolled observational study is proposed. All women presenting to the gynaecology outpatient clinic with heavy menstrual bleeding (HMB) in the absence of recognizable pelvic pathology, as determined by one or all of a normal pelvic ultrasound, hysteroscopy and / or endometrial biopsy, refractory to medical therapy that persists despite treatment with recommended pharmacological agents, who have no desire to preserve their fertility and are willing to have an endometrial ablation will be invited to participate. Eligible women with HMB will undergo RFA G4 endometrial ablation in either an inpatient or outpatient setting according to their preference. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endometrial ablation (4th gen) | Device | Radiofrequency Bipolar endometrial ablation device that is inserted into the uterine cavity to destroy the endometrial lining |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amenorrhoea | Two Likert-type ordinal scales will be used to assess the change in menstrual blood loss using the questions and following response categories: 'How would you describe your menstrual periods?': 'No bleeding', 'Spotting or discharge only', 'Light bleeding', 'Moderate bleeding', 'Heavy bleeding' and 'Compared to before treatment, would you say that your heavy menstrual bleeding is: 'Much better, 'A little better', 'Same', 'Worse'. These scales will be administered in our study at 6, 12 and 60 months after the intervention. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue scale for assessment of pain | This technique involves use of 10 cm line on a piece of paper representing a continuum of the patients' opinion of the degree of pain. It is explained to the patient that the one extreme of the line represents "no pain at all" while the other represents "as much pain as she can possibly imagine". The subject rates the degree of pain by placing a mark on the line and scale values are obtained by measuring the distance from zero to that mark. The reliability of visual analogue scales in the assessment of pain has been established as reproducible and accurate. These scales will be administered in our study immediately following treatment, at one hour post treatment and on discharge from hospital. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justin Clark, MD | Birmingham Women's NHS Foundation Trust | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 1. Royal College of Obstetricians and Gynaecologists. The initial management of menorrhagia. Evidence-Based Clinical Guideline No.4.London: RCOG Press; 1999. | ||
| Background | 2. Royal College of Obstetricians and Gynaecologists. The Management of Menorrhagia in Secondary Care. Evidence-Based Clinical Guideline No.5.London: RCOG Press; 1999. |
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| ID | Term |
|---|---|
| D008595 | Menorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D055356 | Endometrial Ablation Techniques |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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| 6 months |
| Disease specific health-related quality of life | The multi-attribute utility assessment for menorrhagia questionnaire attempts to capture the consequences of menorrhagia on these domains with 6 questions each with 4 levels of response giving an overall composite score out of 100. | 6 months |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |