Classici Stranieri

by Julia F. van der Meulen, Marlies Y. Bongers, Lisa G. van der Zee, Jaklien C. Leemans, Ruben G. Duijnhoven, Robert A. de Leeuw, Lucilla E. Overdijk, Celine M. Radder, Lucet F. van der Voet, Nicol A. C. Smeets, Huib A. A. M. van Vliet, Wouter J. K. Hehenkamp, Arentje P. Manger, Arianne C. Lim, Louisette W. Peters, Nicole Horree, Justine M. Briët, Jan Willem van der Steeg, Sjors F. P. J. Coppus, Helen S. Kok

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. Womenwith clotting disorders or with severe anemia (Hb 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 withPSA (n = 106) or GA (n = 103). Mean age was 45.1 [SD 6.4] yearsinthe PSA group versus 45.0 [7.7] yearsin the GA group. For 98/106 womenin the PSA group and 89/103 womenin the GA group, data were available for analysis of the primary outcome.Hysteroscopic resection was completein 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).