Additional benefit of hemostatic sealant in preservation of ovarian reserve during laparoscopic ovarian cystectomy: a multi-center, randomized controlled trial.

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-Müllerian 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: A prospective, multi-center randomized trial was 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-point was 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, preoperative AMH levels, 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, post-operative AMH levels were lower than preoperative AMH levels (all P < 0.001). The rate of decline of AMH levels was 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.

STUDY FUNDING/COMPLETING OF INTERESTS: This study was supported by the Medical Research Funds from Kangbuk Samsung Hospital. No conflict of interest is declared.

TRIAL REGISTRATION NUMBER

www.clinicaltrials.gov, no. NCT01857466.