Procedural sedation for hysteroscopic myomectomy: cost effectiveness and patient preference.
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Hysteroscopic myomectomies are performed in the majority of Dutch hospitals. The number of procedures for submucosal type 0 or I myomas between 1-3 cm performed in the operating room is estimated to be 3000 per year. Hysteroscopic myomectomy is currently performed in daycare under general anesthesia. A considerable cost reduction is expected when procedural sedation (PSA) is applied.
This study aims to demonstrate non-inferiority of complete hysteroscopic resection of submucous myomas under procedural sedation with propofol compared to hysteroscopic resection under general anesthesia.
Secondly, this study aims to compare the cost effectiveness, patient preference, pain, menstrual blood loss (PBAC score), quality of life, return to daily activities/work, hospitalization, (post)operative complications, re-interventions for hysteroscopic resection of submucous myomas under procedural sedation with propofol and for resection under general anesthesia.
Non-inferiority multi center randomised controlled trial
Women with a maximum of 2 symptomatic type 0 or I submucous myomas with a maximum diameter of 3 cm.
- - Minimum age: 18 years
- - Symptomatic type 0 or I submucous myomas
- - Maximum number of myomas: 3
- - Maximum diameter of submucous myomas: 3 cm
- - American Society of Anesthesiologist class 1 or 2
- - Aged under 18 years
- - Inability to understand Dutch
- - American Society of Anesthesiologist class 3 or 4
- - Clotting disorders
- - Severe anemia (Hb under 5.0 mmol/l)
Hysteroscopic resection of submucous myomas under procedural sedation with propofol, compared to general anesthesia
Primary outcome will be the percentage of complete resections, based on ultrasonography 6 weeks postoperatively by an independent gynaecologist or ultrasonographer blinded for the surgery outcome. This ultrasonography should be conducted in the follicular phase (first 14 days) of the menstrual cycle. A complete resection means that there are no signs of an intracavitary remaining of the myoma resected during hysteroscopic myomectomy on the transvaginal ultrasound.
Secondary outcomes are cost effectiveness, patient preference, pain, menstrual blood loss (PBAC score), quality of life, return to daily activities/work, hospitalization, (post)operative complications, re-interventions. These secondary parameters will be assessed by several questionnaires.
The study is designed as a non-inferiority study, in which we want to investigate if hysteroscopic myomectomy under procedural sedation with propofol is non-inferior to the same surgical procedure under general anesthesia. With 205 women randomized we have 90% power to demonstrate non-inferiority, based on an estimated 2,5% incomplete resections in both groups, with an non-inferiority upper limit of 10% incomplete resections defined as non-inferior (i.e. a delta of 7.5%), an alpha of 0.025 and a drop-out rate of 10%.
Economic evaluation will be performed from a societal perspective. Both a cost-effectiveness and cost-utility analysis will be performed.
Total study time 48 months: preparation time 6 months, inclusion period 24 months, follow up 12 months, analysis 6 months
Prof. Dr. M.Y. Bongers, gynaecologist, MMC, Veldhoven
Dr. H.S. Kok, gynaecologist, Alrijne Ziekenhuis, Leiden
Health Technology Assessment
Dr. J.E. Bosmans, assistant professor Health Technology Assessment, VUmc, Amsterdam
Dr. K. Oude Rengerink, epidemiologist, AMC, Amsterdam
Drs. R.I. Tjon-Kon-Fat, methodologist, AMC, Amsterdam
Julia van der Meulen