Methods and findings
uterine fibroid, fibroid, clotting disorders, blood loss, pain, fibroids
UTERINE FIBROID, FIBROID, CLOTTING DISORDERS, BLOOD LOSS, FIBROIDS, SEVERE ANEMIA, COMPLICATIONS
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 A total of 209 women participated in the study and underwent hysteroscopic myomectomy with PSA (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, 