Design: A randomized control, double-blind study.
Setting: A tertiary medical center
Patients or Participants: Patients who underwent elective VH with or without concurrent colporrhaphy and/or anti-incontinence procedures were randomized into two groups.
Interventions: The study group received 1 gram of TXA, and the control group received Sodium-Chloride 0.9% before VH. The surgeons and the patients were blinded to the allocation.
Measurements and Main Results: The primary outcome was an objective assessment of blood loss during the surgery. It was calculated by subtracting the weight of all used towels from the preoperative weight after the operation; 1 g of fluid was converted to 1 mL of blood. The bleeding assessment was performed in two stages. Immediately after the end of the hysterectomy, and following completion of colporrhaphy and TOT, when performed.
Secondary outcomes included the difference in preoperative and postoperative Hemoglobin levels and intra-abdominal hematoma after surgery (according to ultrasound examination). We also studied the blood transfusion rates, bleeding-related complications, and trombone-embolic events.
The primary outcome of intraoperative total blood loss was lower in the study group compared to the placebo group (240±143 vs 421±240 ml, p< 0.01). Intraoperative blood loss was also reduced when we analyzed hysterectomy and concomitant procedures separately (VH: 150±90 vs. 258±149 ml, p=0.002, concomitant procedures: 93±67 vs. 162±127 ml, p=0.03).
The incidence of blood loss 500 mL was also significantly reduced in the study group (3.3% vs 26.7%, respectfully, P=0.02).
No thromboembolic events or death incidents were observed in any of the groups.
Conclusion: Treatment with TXA reduces the overall total blood loss and the incidence of substantial blood loss in vaginal hysterectomy. Therefore, we suggest considering the use of TXA as a prophylactic treatment before vaginal hysterectomy.