Intraoperative tranexamic acid to decrease blood loss during myomectomy: a randomized, double-blind, placebo-controlled trial.

BACKGROUND: Myomectomy is associated with a significant risk of hemorrhage. Tranexamic acid is a synthetic lysine derivative with antifibrinolytic activity used in other surgical disciplines to reduce blood loss during surgery. However, its utility in gynecologic surgery is not well understood. OBJECTIVE: This study aimed to determine the effect of early administration of intravenous tranexamic acid on perioperative bleeding and blood transfusion requirements in women undergoing myomectomy. STUDY DESIGN: This study was a double-blinded, randomized, placebo-controlled trial conducted in an academic teaching hospital. Women with symptomatic fibroids thought to be at risk for large intraoperative blood loss who met the following criteria were included in the study: (1) at least 1 fibroid ≥10 cm, (2) any intramural or broad ligament fibroid ≥6 cm, and/or (3) at least 5 total fibroids based on preoperative imaging. Patients were randomized to receive a single intravenous bolus injection of tranexamic acid 15 mg/kg (intervention group) versus an intravenous bolus injection of saline of equivalent volume (placebo group) 20 minutes before the initial surgical incision. Perioperative bleeding was defined by measuring intraoperative estimated blood loss, change between pre- and postoperative hemoglobin, and frequency of blood transfusions. Estimated blood loss was calculated by combining the blood volume collected within the suction canister and the weight of used sponges. The 2 groups were compared for age; body mass index; perioperative hemoglobin and hematocrit; perioperative blood loss; duration of surgery; blood transfusion requirements; and the number, total weight, and volume of myomas removed. RESULTS: A total of 60 patients (30 per arm) were enrolled into the study between March 1, 2015, and January 29, 2018. Age, body mass index, baseline hemoglobin and/or hematocrit, number and total weight of myomas removed, and size of myomas did not differ between arms. Of 60 patients, 32 (53%) had laparoscopic myomectomy, 24 (40%) had robotic myomectomy, and 4 (7%) had laparotomy. Median estimated blood loss was 200 mL for the tranexamic acid group and 240 mL for the placebo group (P=.88). There was no difference in median duration of surgery (165 vs 164 minutes; P=.64) or change in perioperative hemoglobin (1.00 vs 1.1 g/dL; P=.64). Patients in the tranexamic acid group did not require blood transfusions; however, 4 patients (13.3%) in the placebo group (P=.11) required blood transfusions. CONCLUSION: Intravenous administration of tranexamic acid in patients undergoing laparoscopic or robotic myomectomies was not associated with decreased blood loss.

Predictors of Overnight Admission After Laparoscopic Myomectomy in a High-Volume Minimally Invasive Gynecologic Surgery Setting.

STUDY OBJECTIVE: Our primary goal was to uncover preoperative and intraoperative risk factors that prevented same-day discharge (SDD) after myomectomy in a setting where SDD was the standard of care. Uncovered predictors would serve to enhance patient counseling and medical optimization before surgery. DESIGN: Single-center retrospective cohort study. SETTING: Urban university hospital center, by fellowship-trained minimally invasive gynecologic surgeons. PATIENTS: A total of 315 consecutive patients undergoing minimally invasive myomectomy between March 2012 and May 2018. INTERVENTION: Minimally invasive myomectomy. MEASUREMENTS AND MAIN RESULTS: Preoperative and intraoperative characteristics were collected for analysis as predictors of SDD vs overnight admission. Comparisons of demographic, clinical, imaging, and operative characteristics were made using appropriate statistical methods for normally distributed, skewed, and categorical variables. Length of stay was analyzed as a categorical variable, SDD vs overnight admission. A logistic regression model was used to evaluate SDD vs any overnight stay. Out of the 315 patients undergoing laparoscopic myomectomy, 208 (66.03%) were discharged on the same day, and 107 (33.96%) were admitted for at least 1 day after surgery. The patients were more likely to be admitted overnight if they were of Asian ethnicity (p = .01), or if they had a lower preoperative Hct (36.15 vs 37.57; p < .003). An increase in any myoma characteristic metric was associated with overnight stay after surgery; these included mean myoma weight (512.0 g vs 310.1 g; p < .001), estimated size of the largest myoma on imaging (9.01 cm vs 7.77 cm; p < .001), and number of myomas removed (6.59 vs 5.57; p = .021). Other statistically significant differences between the overnight admission and SDD groups were mean estimated blood loss (599.4 mL vs 221.9 mL; p < .001), operative time (224.4 minutes vs 140.9 minutes; p < .001), and surgery end time (15:02 hours vs 12:43 hours; p < .001). Intraoperative complications associated with overnight admission were estimated blood loss >1 L (p < .001) and any intraoperative transfusion (p < .001). The adjusted logistic regression model identified an increase in operative time (by 60 minutes) and later surgery end time (by 60 minutes) as predictors of an overnight stay, whereas an 5% increase in preoperative hematocrit was associated with a 34% decrease in odds for an overnight stay. CONCLUSION: Perioperative factors, such as preoperative hematocrit, and myoma characteristics, as well as intraoperative factors, such as prolonged operative time and surgery end-time, are independent predictors of overnight hospital admission after minimally invasive myomectomy. Our present data can be used to provide better patient counseling before surgery.