Background
Methods
Objective
Trial design and setting
Eligibility criteria
Inclusion criteria
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A minimum age of 18 years
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A maximum of 3 symptomatic type 0 and type 1 submucosal fibroids
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A maximum diameter of 3.5 cm (as diagnosed by transvaginal ultrasonography)
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American Society of Anaesthiologists (ASA) class 1 or 2
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Sufficient knowledge of Dutch or English language to fully understand the study and complete the questionnaires
Exclusion criteria
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Presence of clotting disorders
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Severe anemia (Hb under 5.0 mmol/l)
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ASA class 3 or 4
Interventions
Outcome measures
Primary outcome measures
Secondary outcome measures
Patient recruitment
Randomisation
Blinding
Data collection
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Baseline characteristics
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Characteristics registered during and after the procedure
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Questionnaires
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The EuroQoL (EQ-5D-5 L) questionnaire (15 questions) to assess the quality of life [19].
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Recovery Index (RI-10) questionnaire (10 questions): to assess a patients’ recovery process [21].
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Medical Consumption Questionnaire (iMCQ): for cost effectiveness analysis [22].
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Productivity Cost Questionnaire (iPCQ) to assess productivity loss [23].
Side effects, NRS | EQ-5D-5 L | PBAC | UFS-QoL | RI-10 | iMCQ | iPCQ | Re-intervention | TVU | |
---|---|---|---|---|---|---|---|---|---|
Baseline | X | X | X | X | |||||
24 h | X | X | X | ||||||
2 weeks | X | X | |||||||
6 weeks | X | ||||||||
8 weeks | X | X | X | X | X | X | |||
6 months | X | X | X | ||||||
12 months | X | X | X | X | X |