Outcomes
fibroid, NRS, pain
ADVERSE EVENTS, FIBROID, APPENDIX
The primary outcome was the percentage of complete resections, evaluated by transvaginal ultrasonography (TVU) (contrast sonography when TVU was inconclusive) 6 weeks postoperatively. Complete resection was defined as the absence of an intracavitary remnant of the fibroid (s) resected during hysteroscopic myomectomy. TVU was performed by an experienced sonographer or gynecologist blinded for the treatment arm and the surgery outcome. If it was concluded that resection was incomplete based on TVU, the images were adjudicated by an independent review committee, blinded for the type of anesthesia and the surgeon’s judgment on completeness during the procedure. When applicable, the result of the TVU was recorded as complete after adjudication.Secondary outcomes were as follows: completeness of resection as judged by the surgeon during the procedure; pain (Numeric Rating Scale (NRS)) score postprocedure, at discharge and 24 hours postoperatively as measured through a self-tailored questionnaire (Appendix 1 in All questionnaires were completed online. Local research nurses in the participating hospitals were responsible for collection of baseline and follow-up data from the patients’ medical records. Serious adverse events (SAEs) were reported by the local investigator to the principal investigator, who then informed the ethics committee within 15 days.