Transcervical intralesional vasopressin injection compared with placebo in hysteroscopic myomectomy: a randomized controlled trial.

Abstract

To evaluate the efficacy of transcervical intralesional vasopressin injection to submucous myoma in hysteroscopic myomectomy from 2011 to 2014. This was a prospective, randomized, double-blind study in a single center. Forty premenopausal women with symptomatic submucous myoma requiring hysteroscopic myomectomy were randomized to transcervical intralesional vasopressin injection or placebo in a 4:4 ratio. The primary outcome was operative time. Secondary outcomes including fluid volumes, blood loss, and visual clarity were compared between the two groups. The median duration for myomectomy was 19.9 minutes (range 3.1-54.2 minutes) in the vasopressin group compared with 29.0 minutes (range 8.0-60.9 minutes) in the placebo group, a nonsignificant difference (P=.14). There were significant reductions in the median volume of fluid used (4,200 mL [range 1,300-21,000 mL] compared with 9,800 mL (range 1,500-23,000 mL; P=.004) and fluid intravasation (0 mL [range 0-3,100] compared with 300 mL [range -150-3,150 mL; P=.029) in the vasopressin group. The median intraoperative blood loss was reduced (5 mL [range 1-50 mL] compared with 20 mL [range 1-150 mL; P=.002). The operative surgeon rated that 95% of the vasopressin group had "minimal" bleeding compared with 36.8% in the placebo group. The surgical field (visual analog scale [VAS] 9 [range 2-10] compared with 6 [range 2-10; P<.001]; 0=worst visual clarity, 10=best visual clarity) and the effluent fluid (VAS 1 [range 0-7] compared with 4 [range 0-8; P<.001]; 0=clear, 10=unclear) were statistically significantly clearer in the vasopressin group. Transcervical intralesional vasopressin injection in hysteroscopic myomectomy did not reduce operative time but did reduce volume of inflow fluid, fluid intravasation, intraoperative blood loss, and improving visual clarity. Centre for Clinical Research and Biostatistics, http://www.cct.cuhk.edu.hk/Registry/publictriallist.aspx, CUHK_CCT00291.