Julia F. van der Meulen

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.

Procedural sedation and analgesia versus general anesthesia for hysteroscopic myomectomy (PROSECCO trial): A multicenter randomized controlled trial

Background Hysteroscopic resection is the first-choice treatment for symptomatic type 0 and 1 fibroids. Traditionally, this was performed under general anesthesia. Over the last decade, surgical procedures are increasingly being performed in an outpatient setting under procedural sedation and analgesia. However, studies evaluating safety and effectiveness of hysteroscopic myomectomy under procedural sedation are lacking. This study aims to investigate whether hysteroscopic myomectomy under procedural sedation and analgesia with propofol is noninferior to hysteroscopic myomectomy under general anesthesia. Methods and findings This was a multicenter, randomized controlled noninferiority trial conducted in 14 university and teaching hospitals in the Netherlands between 2016 and 2021. Inclusion criteria were age ≥18 years, maximum number of 3 type 0 or 1 fibroids, maximum fibroid diameter 3.5 cm, American Society of Anesthesiologists class 1 or 2, and having sufficient knowledge of the Dutch or English language. Women with clotting disorders or with severe anemia (Hb < 5.0 mmol/L) were excluded. Women were randomized using block randomization with variable block sizes of 2, 4, and 6, between hysteroscopic myomectomy under procedural sedation and analgesia (PSA) with propofol or under general anesthesia (GA). Primary outcome was the percentage of complete resections, assessed on transvaginal ultrasonography 6 weeks postoperatively by a sonographer blinded for the treatment arm and surgical outcome. Secondary outcomes were the surgeon’s judgment of completeness of procedure, menstrual blood loss, uterine fibroid related and general quality of life, pain, recovery, hospitalization, complications, and surgical reinterventions. Follow-up period was 1 year. The risk difference between both treatment arms was estimated, and a Farrington–Manning test was used to determine the p-value for noninferiority (noninferiority margin 7.5% of incomplete resections). Data were analyzed according to the intention-to-treat principle, including a per-protocol analysis for the primary outcome. A total of 209 women participated in the study and underwent hysteroscopic myomectomy with PSA (n = 106) or GA (n = 103). Mean age was 45.1 [SD 6.4] years in the PSA group versus 45.0 [7.7] years in the GA group. For 98/106 women in the PSA group and 89/103 women in the GA group, data were available for analysis of the primary outcome. Hysteroscopic resection was complete in 86/98 women (87.8%) in the PSA group and 79/89 women (88.8%) in the GA group (risk difference −1.01%; 95% confidence interval (CI) −10.36 to 8.34; noninferiority, P = 0.09). No serious anesthesiologic complications occurred, and conversion from PSA to GA was not required. During the follow-up period, 15 serious adverse events occurred (overnight admissions). All were unrelated to the intervention studied. Main limitations were the choice of primary outcome and the fact that our study proved to be underpowered. Conclusions Noninferiority of PSA for completeness of resection was not shown, though there were no significant differences in clinical outcomes and quality of life. In this study, hysteroscopic myomectomy for type 0 and 1 fibroids with PSA compared to GA was safe and led to shorter hospitalization. These results can be used for counseling patients by gynecologists and anesthesiologists. Based on these findings, we suggest that hysteroscopic myomectomies can be performed under PSA in an outpatient setting. Trial registration The study was registered prospectively in the Dutch Trial Register (NTR 5357; registration date: 11 August 2015; Date of initial participant enrollment: 18 February 2016).