Discussion
hemorrhage, reduction of blood loss, VTE, bleeding
BLEEDING, MINOR, INFECTED HEMATOMA, HEMORRHAGE, COMPLICATIONS
In the present study, TXA did not show a significant reduction in the use of hemostatic clips. However, peroperative administration of TXA in patients undergoing SG was associated with significant positive effects on clinical parameters, and minor complications correlated with hemorrhage and LOS, without increasing side effects, such as the risk of VTE.To the best of our knowledge, this is the first randomized controlled trial investigating the effectiveness of peroperative administration of TXA in metabolic surgery. In other surgical fields, clinical trials have shown positive effects of TXA on all-cause mortality, reduction of blood loss, and a reduction risk of reoperations, without an increase of VTE [The available evidence of TXA in metabolic surgery comes from non-randomized and retrospective studies, showing less staple line bleedings in SG, low reoperation rates, and no increase in VTE [Retrospective studies have shown a decrease in hemoglobin and an increase in heart rate as early signs of hemorrhage after metabolic surgery [As hypothesized, interventions for hemorrhage were rare, as the (limited) sample size was based on reduced use of clips for peroperative bleeding points. One radiological intervention was performed in the placebo-group, due to an infected hematoma originating from the staple line, compared to none in the TXA-group. This reported hemorrhage rates are in line with larger series (2–3%) [TXA is an inexpensive drug and might be of economic value [This study had several limitations, including the fact that it was conducted in a single institution. Nevertheless, the double-blinded randomized design, in which all operations were performed by expert bariatric surgeons, makes the results widely applicable. Secondly, the primary endpoint consisted of factors indirectly associated with hemorrhage. The definition of this endpoint was chosen in order to limit the sample size and minimize the number of patients exposed to potential risks, as this is the first randomized trial investigating TXA in metabolic surgery. Thirdly, the study might have been underpowered to show a reduction in use of clips. Based on the current results, a sample size of 316 would have been required to demonstrate a statistically significant reduction in hemostatic clip use between TXA and placebo (