European Journal of Obstetrics & Gynecology and Reproductive Biology
Intravenous tranexamic acid use in myomectomy: A prospective randomized double-blind placebo controlled study
Introduction
All surgical procedures are associated with bleeding, the amount of which depends on surgical and non-surgical factors. Myomectomy is one of the gynecological operations associated with significant blood loss. In most cases, adequate surgical haemostasis is provided with advanced surgical techniques, along with blood transfusion therapy which makes myomectomy an alternative operation to hysterectomy in cases with symptomatic leiomyomata requiring surgery [1]. However, excess perioperative bleeding remains a major complication following myomectomy that might necessitate hysterectomy resulting in increased morbidity and mortality. In such cases, pharmacological interventions may be of additional benefit. Pharmacological manipulation of the coagulation cascade with antifibrinolytic treatment, especially aprotinin, tranexamic acid (TA), epsilon-aminocaproic acid, desmopressin and recombinant factor VIIa are being used both in prophylaxis and therapeutically to stop bleeding [2].
Tranexamic acid, a synthetic lysine derivative with antifibrinolytic activity has been used since 1960s in a variety of clinical settings where antifibrinolytic therapy is appropriate [3]. TA has been used to reduce blood loss and to reduce the need for allogeneic blood transfusion especially in cardiac surgery, liver transplantation and some orthopedic surgical procedures, with variable results [4].
Lack of scientific evidence on the use of antifibrinolytic agent TA in patients undergoing gynecological surgery promoted us to conduct this study. To define an effective and safe pharmacological therapy for reducing blood loss and transfusion requirements, we evaluated the effect of TA on peri- and postoperative bleeding and the number of blood transfusions needed in women undergoing myomectomy.
Section snippets
Materials and methods
The number of patients needed for this study were calculated on the basis of the previous report by Benoni et al. [5] who had reported an average reduction in blood loss of 255 ml in cases receiving tranexamic acid. A sample size of 50 per group was required to detect a 250 ml difference according to preoperative blood loss between groups with a power of 85% at the 5% significance level. In the Department of Gynecology, a total of 167 patients underwent myomectomy between 1 March 1 and 30
Results
The mean age of the patients were 35.3 ± 5 years (ranged from 23 to 40). Twelve of the cases had a medical history of previous abdominal surgery including laparoscopy in four, appendectomy in two, cesarean section in four and myomectomy in two patients (six in each group). Most of the operations were performed via pfannestiel incision; in 15 cases midline vertical incision were performed (7 in TA and 8 in saline group).
Table 1 summarizes the patient characteristics, preoperative blood analysis,
Comment
In practice, TA is used in a variety of clinical settings in which antifibrinolytic activity is thought to be beneficial. TA is used in gynecology and obstetrics in different hemorrhagic conditions. Most commonly, it is used for treatment of idiopathic menorrhagia, which is an effective and well tolerated treatment when administered orally [3]. Bleeding associated with pregnancy (placental abruption, placenta previa) has also been treated with TA [6], [7], [8]. Moreover, oral administration of
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