A Randomized Controlled Trial of Combined Vaginal Misoprostol and Pervascular Vasopressin vs. Vasopressin Alone During Robotic Myomectomy

Abstract

Study Objective To compare the estimated blood loss, change in peri-operative hematocrit, and operative time during robotic myomectomy when using either vaginal misoprostol with perivascular vasopressin or perivascular vasopressin alone. Design We conducted a single center, double blind randomized controlled trial to compare changes in blood loss using preoperative vaginal misoprostol and perivascular vasopressin with surgeries using perivascular vasopressin alone, during robotic assisted laparoscopic surgeries. Our primary outcomes were intraoperative blood loss (measured by volume in the suction canister minus amount of irrigation), operative time, surgeons’ estimated blood loss and change in postoperative hemoglobin and hematocrit from preoperative hematocrit. Our secondary outcome was to assess the side effects of misoprostol use. Setting Robotic myomectomy. Patients or Participants A total of 100 women were assessed for eligibility, 79 consented to participate in the study. Five consents were excluded for analysis due to missing information. Thereby 74 patients were used for analysis, 42 women were randomized into vasopressin alone group (Group 1) and 32 were randomized into the vasopressin and misoprostol group (Group II). Interventions The addition of 400mcg of vaginal misoprostol. Measurements and Main Results The change in pre-op to post-op hematocrit (HCT) was 2.5% in Group 1 and 3.2% in Group II, with a p value of 0.491. There were also non-statistical differences in estimated blood loss (EBL) by group, 247ml vs 246ml, respectively, p=0.983. Surgery time, between the two groups was non-statistically different as well, 173.9 min vs 181.3 min respectively, p = 0.6945. Conclusion In this randomized controlled trial, we did not observe a decrease in operative blood loss, operative time, and postoperative hemoglobin during robot-assisted laparoscopic myomectomy using vaginal misoprostol with perivascular vasopressin versus perivascular vasopressin alone.