Jaklien C. Leemans

Procedural sedation and analgesia versus general anesthesia for hysteroscopic myomectomy: A cost‐effectiveness analysis alongside a randomized controlled trial

Abstract Introduction Hysteroscopic myomectomy is the first‐choice treatment for symptomatic type 0 and 1 fibroids and was traditionally performed under general anesthesia. Over the last decade, surgical procedures have increasingly been performed in an outpatient setting under procedural sedation and analgesia. However, studies evaluating the safety and cost‐effectiveness of hysteroscopic myomectomy under procedural sedation and analgesia are lacking. This study aimed to assess the cost‐effectiveness of procedural sedation and analgesia with propofol in an outpatient setting for hysteroscopic myomectomy compared to general anesthesia in an operating room. Material and Methods This was a cost‐effectiveness analysis from a societal perspective alongside a multicenter randomized controlled non‐inferiority trial. It was conducted in 14 Dutch university and teaching hospitals. Women aged ≥18 years with symptomatic type 0/1 fibroids (maximum number 3, maximum diameter 3.5 cm), sufficient knowledge of Dutch/English, and American Society of Anesthesiologists class 1/2 were included. A total of 209 women were randomized to hysteroscopic myomectomy with procedural sedation and analgesia in an outpatient setting ( n  = 106) or general anesthesia in an operating room ( n  = 103). The primary outcome of the clinical trial was the percentage of complete resections measured by transvaginal ultrasonography 6 weeks postoperatively (non‐inferiority margin 7.5% of incomplete resections). Societal costs and quality‐adjusted life years (QALYs) were assessed. Societal costs were related to the percentage of complete resections and QALYs. Incremental Cost‐Effectiveness Ratios (ICERs) were calculated. Uncertainty surrounding these was estimated using bootstrapping. Follow‐up period was 12 months. Dutch Trial Register NTR 5357. Results Hysteroscopic resection was complete in 86/98 women (87.8%) with procedural sedation and analgesia and 79/89 women (88.8%) with general anesthesia, mean difference −0.0052 (95% CI −0.097 to 0.086). Non‐inferiority could not be demonstrated. There was a statistically significant difference in costs between procedural sedation and analgesia and general anesthesia (€−2577, 95% CI −3950 to −1157), but not in QALYs (0.011, 95% CI −0.019 to 0.040). The ICER per additional complete resection was €498 797 and for QALYs the ICER showed that procedural sedation and analgesia was dominant over general anesthesia. Conclusions In this study, procedural sedation and analgesia for hysteroscopic myomectomy in an outpatient setting is cost‐effective compared to general anesthesia in an operating room, although non‐inferiority for complete resections could not be demonstrated. We therefore suggest the outpatient use of procedural sedation and analgesia for hysteroscopic myomectomy.