Peroperative administration of tranexamic acid in sleeve gastrectomy to reduce hemorrhage: a double-blind randomized controlled trial

Abstract

Introduction In metabolic surgery, hemorrhage is the most common major complication. This study investigated whether peroperative administration of tranexamic acid (TXA) reduced the risk of hemorrhage in patients undergoing laparoscopic sleeve gastrectomy (SG). Methods In this double-blind randomized controlled trial, patients undergoing primary SG in a high-volume bariatric hospital were randomized (1:1) to receive 1500-mg TXA or placebo peroperatively. Primary outcome measure was peroperative staple line reinforcement using hemostatic clips. Secondary outcome measures were peroperative fibrin sealant use and blood loss, postoperative hemoglobin, heart rate, pain, major and minor complications, length of hospital stay (LOS), side effects of TXA (i.e., venous thrombotic event (VTE)) and mortality. Results In total, 101 patients were analyzed and received TXA (n = 49) or placebo (n = 52). There was no statistically significant difference in hemostatic clip devices used in both groups (69% versus 83%, p = 0.161). TXA administration showed significant positive changes in hemoglobin levels (millimoles per Liter; 0.55 versus 0.80, p = 0.013), in heart rate (beats per minute; -4.6 versus 2.5; p = 0.013), in minor complications (Clavien–Dindo ≤ 2, 2.0% versus 17.3%, p = 0.016), and in mean LOS (hours; 30.8 versus 36.7, p = 0.013). One patient in the placebo-group underwent radiological intervention for postoperative hemorrhage. No VTE or mortality was reported. Conclusion This study did not demonstrate a statistically significant difference in use of hemostatic clip devices and major complications after peroperative administration of TXA. However, TXA seems to have positive effects on clinical parameters, minor complications, and LOS in patients undergoing SG, without increasing the risk of VTE. Larger studies are needed to investigate the effect of TXA on postoperative major complications. Graphical abstract

The Role of Tranexamic Acid in Sleeve Gastrectomy: A Systematic Review and Meta-Analysis

“…Regarding the appraised RCT, Sermet and Ozsoy achieved a low risk of bias regarding all assessed domains [ 21 ]. Likewise, Hart et al, except in the detection bias domain, was of high risk [ 22 ]. Alhomoud [ 20 ] achieved low-risk attrition and reporting biases but unclear risk in all other domains (Figure 2 ).…”

“…Operative time (minutes): Five studies with substantial heterogeneity provided data from 644 patients [ 18 , 21 , 22 , 28 , 29 ] that revealed significantly shorter operative time in the TXA group compared to the control group (MD= -5.84, 95%CI [-9.62, -2.05], P=0.003, I2=73%) (Figure 5 ).…”

“…Length of hospital stay (days): Analysis of three homogenous studies enrolling 476 patients [ 22 , 28 , 29 ] showed a significantly shorter hospital stay associated with the TXA group compared to the control group (MD=-0.24, 95%CI [-0.32, -0.17], P< 0.00001, I2 =0%) (Figure 8 ).…”

“…Initial searching through Scopus, Cochrane Library, PubMed, and Web of Science resulted in 46 studies, of which 16 duplicates were found and omitted. Thirty studies were screened by titles and abstracts, 10 studies were eligible for full-text screening, and six studies were ultimately eligible for our review [18,[20][21][22]28,29] (Figure 1).…”

“…Recently, Sermet and Hart conducted a high-quality RCT involving a total of 278 obese patients who had undergone LSG. They compared TXA with a placebo regarding safety and efficacy outcomes, including intraoperative bleeding, postoperative bleeding, and thromboembolic events [ 21 , 22 ]. Consequently, we carried out this systematic review and meta-analysis to thoroughly evaluate the latest available evidence regarding the safety and efficacy outcomes of TXA when administered to obese patients undergoing LSG.…”