Hysteroscopy, myomas, fibroids, resection, procedural sedation, cost-effectiveness, propofol, hysteroscopische myoomresectie
Conditions
Interventions
- Procedural sedation and analgesia in an outpatient setting: According to guidelines from the Health Care Inspectorate (IGZ) and Dutch Institute for Healthcare Improvement (CBO) non-anesthesiologist
Sponsors
Máxima Medisch Centrum Veldhoven
Eligibility
Inclusion criteria
Inclusion criteria: The following women will be included: - A minimum age of 18 years - A maximum of 3 symptomatic type 0 and type 1 submucosal fibroids - A maximum diameter of 3.5 cm (as diagnosed by transvaginal ultrasonography) - American Society of Anaesthiologists (ASA) class 1 or 2 - Sufficient knowledge of Dutch or English language to fully understand the study and complete the questionnaires
Exclusion criteria
Exclusion criteria: - Presence of clotting disorders - Severe anemia (Hb under 5.0 mmol/l) - ASA class 3 or 4
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome will be the percentage of complete resections, evaluated by transvaginal ultrasonography (TVU) (contrast sonography if TVU is inconclusive) 6 weeks postoperatively. TVU will be performed by an independent gynecologist or ultrasonographer blinded for the surgery outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are cost effectiveness, pain, menstrual blood loss (PBAC score), quality of life as assessed by questionnaires: EuroQoL (EQ-5D-5L), Recovery Index (RI-10) and Uterine Fibroid Symptoms – Quality of Life questionnaire (UFS-QoL), return to daily activities/work, hospitalization, Medical Consumption Questionnaire (iMCQ): for cost effectiveness analysis, Productivity Cost Questionnaire (iPCQ) to assess productivity loss, (post)operative complications, re-interventions. | — |
Contacts
Public ContactJulia van der Meulen
Máxima Medisch Centrum - Department of Obstetrics and Gynaecology
Outcome results
None listed