Methods
Design and patients
Randomization and masking
Procedures
Outcomes
Statistical analysis
Results
TXA (n = 49) | Placebo (n = 52) | p-value | |
---|---|---|---|
Age (years) (mean, SD) | 36.0 (10.9) | 36.8 (12.3) | p = 0.632a |
Weight (kg) (mean, SD) | 118.8 (19.8) | 120.1 (24.4) | p = 0.671a |
Body Mass Index (kg/m2) (mean, SD) | 42.3 (5.4) | 41.5 (5.3) | p = 0.444a |
Female gender | 38 (77.6%) | 42 (80.8%) | p = 0.690b |
Hypertension | 8 (16.3%) | 12 (23.1%) | p = 0.395b |
Diabetes mellitus | 2 (4.1%) | 3 (5.8%) | p = 1.000c |
Dyslipidemia | 5 (10.2%) | 5 (9.6%) | p = 1.000c |
Obstructive sleep apnea | 17 (34.7%) | 18 (34.6) | p = 0.993b |
Severe joint pain | 8 (16.3%) | 8 (15.4%) | p = 0.897b |
Gastroesophageal reflux disease | 4 (8.2%) | 5 (9.6%) | p = 1.000c |
Possible interacting medication (risk > 0.1%) | 6 (12.2%) | 4 (7.7%) | p = 0.518c |
Heart rate (bpm) (mean, SD) | 81.8 (10.3) | 79.2 (12.4) | p = 0.245a |
Systolic blood pressure (mmHg) (mean, SD) | 129 (13.4) | 132 (16.9) | p = 0.254a |
Diastolic blood pressure (mmHg) (mean, SD) | 75 (10.7) | 74 (12.1) | p = 0.599a |
Hemoglobin (mmol/L) (mean, SD) | 8.8 (0.8) | 8.7 (0.6) | p = 0.937a |
Primary endpoint
TXA (n = 49) | Placebo (n = 52) | Between-group difference (95% CI) or RR (95% CI) | p-value | |
---|---|---|---|---|
Peroperative hemostatic clips used | 34 (69.4%) | 43 (82.7%) | RR: 0.84 (0.67 to 1.05) | p = 0.161b |
Number of peroperative hemostatic clips used (mean, SD) | 3.54 (2.7) | 4.17 (2.4) | 0.18 (− 0.18 to 0.70) | p = 0.377a |
Fibrin sealant use peroperative | 19 (38.8%) | 23 (44.2%) | RR: 0.88 (0.55 to 1.40) | p = 0.687b |
Staple device Cartridge GOLD (3.0 mm) Cartridge BLUE (2.4 mm) Cartridge GREEN (3.4 mm) | 49 (100%) 49 (100%) 4 (8.9%) | 52 (100%) 52 (100%) 5 (9.6%) | p = 1.000c | |
Blood loss (milliliter) (mean, SD) | 0 | 0 | UTD | UTD |
Length of surgery (minutes) (mean, SD) | 34.1 (11.8) | 34.8 (8.7) | 0.71 (− 4.80 to 3.39) | p = 0.733a |
Secondary endpoints
TXA (n = 49) | Placebo (n = 52) | Between-group difference (95% CI) or RR (95% CI) | p-value | |
---|---|---|---|---|
Decrease in Hb level (mmol/L) (mean, SD) | − 0.55 (0.48) | − 0.80 (0.50) | 0.25 (0.05 to 0.44) | p = 0.013a* |
Increase in heart rate (bpm) (mean, SD) | − 4.6 (13.5) | 2.5 (14.8) | 7.11 (1.53 to 12.69) | p = 0.013a* |
Pain (numeric rating scale) (mean, SD) | 3.6 (1.9) | 4.0 (1.7) | − 0.41 (− 1.11 to 0.30) | p = 0.256a |
Intervention for hemorrhage | 0 (0%) | 1 (1.9%) | UTD | UTD |
Patients with extra Hb monitoring | 7 (14.3%) | 17 (32.7%) | RR: 0.44 (0.20 to 0.96) | p = 0.037b* |
Minor complications due to hemorrhage | 1 (2.0%) | 9 (17.3%) | RR: 0.12 (0.02 to 0.90) | p = 0.016c* |
Hematemesis | 0 (0%) | 1 (1.9%) | UTD | UTD |
Melena | 0 (0%) | 1 (1.9%) | UTD | UTD |
TXA for decrease of > 1.5 Hb | 1 (2.0%) | 7 (13.5%)d | RR: 0.15 (0.02 to 1.19) | p = 0.060c |
Infected abdominal wall hematoma | 0 (0%) | 1 (3.8%) | UTD | UTD |
General complications | 3 (6.1%) | 10 (19.2%) | RR: 0.32 (0.09 to 1.09) | p = 0.073c |
Length of stay (hours) (mean, SD) | 30.8 (6.3) | 34.7 (15.3) | − 5.9 (− 10.5 to − 1.3) | p = 0.013a* |
Possible side effects TXA | ||||
VTE | 0 (0%) | 0 (0%) | UTD | UTD |
Nausea | 21 (42.9) | 21 (40.4) | RR: 1.06 (0.67 to 1.69) | p = 0.842b |
Vomiting | 8 (16.3%) | 6 (11.5%) | RR: 1.70 (0.60 to 4.84) | p = 0.381b |
Systolic bp (mmHg) (mean, SD) | 135.7(16.5) | 138.8 (17.7) | − 3.09 (− 9.88 to 3.70) | p = 0.368a |
Diastolic bp (mmHg) (mean, SD) | 72.5 (9.4) | 73.3 (10.5) | − 0.80 (− 4.74 to 3.14) | p = 0.687a |
Mortality | 0 (0%) | 0 (0%) | UTD | UTD |