Preservation of Ovarian Reserve and Hemostasis during Ovarian Cystectomy: A Randomised Controlled Trial

Abstract

Study Objective This study aims to evaluate the safety and efficacy of the hemostatic agent on ovarian reserve during laparoendoscopic single-site (LESS) ovarian cystectomy. Design Investigator-initiated, single-blinded, randomized controlled trial. Setting LESS ovarian cystectomy. Patients or Participants From December 2017 to February 2019, 52 patients with benign unilateral ovarian cysts were enrolled. Interventions We performed LESS unilateral ovarian cystectomies based on the same surgical protocol, minimizing bipolar coagulation. In the coagulation group, the patients received hemostasis using bipolar coagulation, whereas oxidized cellulose polymer was applied in the hemostatic agent group. Measurements and Main Results We compared the hemoglobin (Hb) and anti-Müllerian hormone (AMH) levels, and ovarian volumes just before surgery, and two days (2D-POST), one week (1W-POST), and three months after surgery (3M-POST), and the decline ratio. There were no differences in the Hb levels, AMH levels, or ovarian volumes. Moreover, there were no differences in the decline ratio of the Hb levels and ovarian volumes between the two groups, whereas the decline ratio of serum AMH levels was greater at 3M-POST in the coagulation than in the hemostatic agent group (median intention-to-treat [ITT], -36.7 vs. -13.3%; per-protocol [PP], -36.8 vs. -13.3%; P < 0.05). Notably, the difference of decline ratio of serum AMH levels was prominent in the coagulation than in the hemostatic agent groups when only patients with endometriosis were included in the analysis (median; ITT, -50.7 vs. -14.4%; PP, -50.7% vs. -14.4%; P < 0.05). There was no difference between the two groups when only patients with non-endometriosis were included in the analysis. Conclusion Oxidized cellulose polymer hemostatic agents may be non-inferior to bipolar coagulation for preserving ovarian reserve and hemostasis during LESS ovarian cystectomy. In particular, the hemostatic agent may be better for preserving ovarian reserve than bipolar coagulation in patients with ovarian endometriosis. This study aims to evaluate the safety and efficacy of the hemostatic agent on ovarian reserve during laparoendoscopic single-site (LESS) ovarian cystectomy. Investigator-initiated, single-blinded, randomized controlled trial. LESS ovarian cystectomy. From December 2017 to February 2019, 52 patients with benign unilateral ovarian cysts were enrolled. We performed LESS unilateral ovarian cystectomies based on the same surgical protocol, minimizing bipolar coagulation. In the coagulation group, the patients received hemostasis using bipolar coagulation, whereas oxidized cellulose polymer was applied in the hemostatic agent group. We compared the hemoglobin (Hb) and anti-Müllerian hormone (AMH) levels, and ovarian volumes just before surgery, and two days (2D-POST), one week (1W-POST), and three months after surgery (3M-POST), and the decline ratio. There were no differences in the Hb levels, AMH levels, or ovarian volumes. Moreover, there were no differences in the decline ratio of the Hb levels and ovarian volumes between the two groups, whereas the decline ratio of serum AMH levels was greater at 3M-POST in the coagulation than in the hemostatic agent group (median intention-to-treat [ITT], -36.7 vs. -13.3%; per-protocol [PP], -36.8 vs. -13.3%; P < 0.05). Notably, the difference of decline ratio of serum AMH levels was prominent in the coagulation than in the hemostatic agent groups when only patients with endometriosis were included in the analysis (median; ITT, -50.7 vs. -14.4%; PP, -50.7% vs. -14.4%; P < 0.05). There was no difference between the two groups when only patients with non-endometriosis were included in the analysis. Oxidized cellulose polymer hemostatic agents may be non-inferior to bipolar coagulation for preserving ovarian reserve and hemostasis during LESS ovarian cystectomy. In particular, the hemostatic agent may be better for preserving ovarian reserve than bipolar coagulation in patients with ovarian endometriosis.