Additional benefit of hemostatic sealant in preservation of ovarianreserve during laparoscopic ovarian cystectomy: A multi-center, randomized controlled trial

摘要

Study question: Is hemostasis by hemostatic sealant superior to that achieved by bipolar coagulation in preserving ovarian reserve in patients undergoing laparoscopic ovarian cystectomy? Summary answer: Post-operative ovarian reserve, determined by serial serum anti-M黮lerian hormone (AMH) levels, was significantly less diminished after ovarian hemostasis when hemostatic sealant was used rather than bipolar coagulation. What is known already: Hemostasis achieved with bipolar coagulation at ovarian bleeding site results in damage to the ovarian reserve. Study design, size, duration: Aprospective, multi-center randomized trialwas conducted on 100 participants with benign ovarian cysts, between December 2012 and October 2013. Participant/materials, setting, methods: Participants were randomized to undergo hemostasis by use of either hemostatic sealant (FloSeal") or bipolar coagulation during laparoendoscopic single-site (LESS) ovarian cystectomy. The primary end-pointwas the rate of decline of ovarian reserve calculated by measuring serum AMH levels preoperatively and 3 months post-operatively. Main results and the role of chance: Age, parity, socio-demographic variables, preoperativeAMHlevels, procedures performed and histologic findings were similar between the two groups of patients. There were also no differences in operative outcomes, such as conversion to other surgical approaches, operative time, estimated blood loss, or perioperative complications between the two groups. In both study groups, postoperativeAMHlevelswere lower than preoperativeAMHlevels (all P< 0.001).The rate of decline ofAMHlevelswas significantly greater in the bipolar coagulation group than the hemostatic sealant group (41.2% [IQR, 17.2-54.5%] and 16.1% [IQR, 8.3-44.7%], respectively, P = 0.004). Limitations, reasons for caution: Some caution is warranted because other ovarian reserve markers such as serum markers (basal FSH and inhibin-B) or sonographic markers were not assessed. Wider implications of the findings: The present study shows that the use of a hemostatic sealant during laparoscopic ovarian cystectomy should be considered, as hemostatic sealant provides the additional benefit of preservation of ovarian reserve.