Sayed Lotfollah Afzali1, Hesam Panahi1, Forouzan Ganji2, Sanaz Ziaei3, Nahad Sedaghat4. 1. Department of Surgery, School of Medicine, Shahrekord University of Medical Sciences, Shahrekord, Iran. 2. Department of Community Medicine, School of Medicine, Shahrekord University of Medical Sciences, Shahrekord, Iran. 3. Department of Pediatric Dentistry, School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran. 4. Alzahra Research Institute, Alzahra University Hospital, Isfahan University of Medical Sciences, Isfahan, Iran. Nahad.sedaghat@gmail.com.
Abstract
BACKGROUND: Nowadays, minimizing the surgical complications of rhinoplasty has gained more importance. Results from previous trials show that Tranexamic acid (TXA) reduces intraoperative bleeding, one of the major complicating factors during rhinoplasty. OBJECTIVE: To contribute to previous evidence by re-evaluating the efficacy of TXA, specifically in reducing intraoperative blood loss and increasing surgical field quality in rhinoplasty. STUDY DESIGN AND METHODS: A randomized placebo-controlled trial was conducted (IRCT20111219008458N2). The outcomes included total intraoperative blood loss, measured by the total volume of fluid collected by suction and gauzes, subtracted by volume of used irrigation fluids, and the quality of surgical field, measured by surgeon's satisfaction on a 5-point Likert scale. Demographics, blood coagulation measures, and clinical data were also collected and were held as covariates in analysis. After blinding, randomization, and group allocations, the intervention group received TXA 10mg/kg and the placebo group normal saline in equal volumes. RESULTS: Data of a total of 80 patients were gathered and analyzed. The total intraoperative blood loss was insignificantly lower (mean difference [95% CI]: - 3.6 ( - 19.19, 11.99), P = 0.65) and surgeon's satisfaction was insignificantly higher (mean difference [95% CI]: 0.18 ( - 0.11, 0.46), P = 0.22) in TXA group. Results were confirmed by multivariable analysis. CONCLUSION: In contrast to most of the previous studies, this study showed only a statistically insignificant decrease in total intraoperative blood loss in patients receiving TXA compared to placebo. Further studies are required to more precisely estimate the efficacy of TXA in reducing blood loss during rhinoplasty. LEVEL OF EVIDENCE: LEVEL I, RANDOMIZED CONTROLLED TRIAL.: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
BACKGROUND: Nowadays, minimizing the surgical complications of rhinoplasty has gained more importance. Results from previous trials show that Tranexamic acid (TXA) reduces intraoperative bleeding, one of the major complicating factors during rhinoplasty. OBJECTIVE: To contribute to previous evidence by re-evaluating the efficacy of TXA, specifically in reducing intraoperative blood loss and increasing surgical field quality in rhinoplasty. STUDY DESIGN AND METHODS: A randomized placebo-controlled trial was conducted (IRCT20111219008458N2). The outcomes included total intraoperative blood loss, measured by the total volume of fluid collected by suction and gauzes, subtracted by volume of used irrigation fluids, and the quality of surgical field, measured by surgeon's satisfaction on a 5-point Likert scale. Demographics, blood coagulation measures, and clinical data were also collected and were held as covariates in analysis. After blinding, randomization, and group allocations, the intervention group received TXA 10mg/kg and the placebo group normal saline in equal volumes. RESULTS: Data of a total of 80 patients were gathered and analyzed. The total intraoperative blood loss was insignificantly lower (mean difference [95% CI]: - 3.6 ( - 19.19, 11.99), P = 0.65) and surgeon's satisfaction was insignificantly higher (mean difference [95% CI]: 0.18 ( - 0.11, 0.46), P = 0.22) in TXA group. Results were confirmed by multivariable analysis. CONCLUSION: In contrast to most of the previous studies, this study showed only a statistically insignificant decrease in total intraoperative blood loss in patients receiving TXA compared to placebo. Further studies are required to more precisely estimate the efficacy of TXA in reducing blood loss during rhinoplasty. LEVEL OF EVIDENCE: LEVEL I, RANDOMIZED CONTROLLED TRIAL.: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
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