Abstract

INTRODUCTION The aim of this study was to evaluate the safety and efficacy of a flowable hemostatic matrix, and their effect for postoperative pancreatic fistula (POPF) after pancreatectomy. METHODS This was a randomized, clinical, single-center, single-blind (participant), non-inferiority, phase IV, and parallel-group trial. The primary endpoint was the incidence of POPF. The secondary endpoints were risk factors for POPF, drain removal days, incidence of complication, 90-day mortality, and length of hospital stay. RESULTS This study evaluated a total of 54 patients, with 26 patients in the intervention group (flowable hemostatic matrix) and 27 patients in the control group (thrombin-coated collagen patch). POPF was more common in the control group than in the intervention group (59.3% vs. 30.8%, p = 0.037). Among participants who underwent distal pancreatectomy (DP), POPF (33.3% vs. 92.3%, p = 0.004) and clinically relevant POPF (8.3% vs. 46.2%, p = 0.027) were more common in the control group. A multivariate logistic regression model identified flowable hemostatic matrix use (p = 0.029) as an independent negative risk factor for POPF. CONCLUSIONS Flowable hemostatic matrix application is a simple, feasible, and effective method of preventing POPF after pancreatectomy, especially for patients with DP.

Abstract

BACKGROUND The aim of this study was to evaluate the safety and efficacy of a flowable hemostatic matrix, and their effects for postoperative pancreatic fistula (POPF) after pancreatectomy. METHODS This was a randomized, clinical, single-center, single-blind (participant), non-inferiority, phase IV, and parallel-group trial. The primary endpoint was the incidence of POPF. The secondary endpoints were risk factors for POPF, drain removal days, incidence of complication, 90-day mortality, and length of hospital stay. RESULTS This study evaluated a total of 53 patients, of whom 26 patients were in the intervention group (flowable hemostatic matrix) and 27 patients were in the control group (thrombin-coated collagen patch). POPF was more common in the control group than in the intervention group (59.3% vs. 30.8%, p = 0.037). Among participants who underwent distal pancreatectomy, POPF (33.3% vs. 92.3%, p = 0.004), and clinically relevant POPF (8.3% vs. 46.2%, p = 0.027) was more common in the control group. A multivariate logistic regression model identified flowable hemostatic matrix use as an independent negative risk factor for POPF, especially in cases of distal pancreatectomy (DP) (odds ratio 17.379, 95% confidential interval 1.453-207.870, p = 0.024). CONCLUSION Flowable hemostatic matrix application is a simple, feasible, and effective method of preventing POPF after pancreatectomy, especially for patients with DP. Non-inferiority was demonstrated in the efficacy of preventing POPF in the intervention group compared to the control group.

Abstract

BACKGROUND Fibrin sealants and topical glue have been studied to reduce the incidence of postoperative pancreatic fistulas (POPF) after pancreatico-enteric anastomosis, but a definitive innovation is still needed. We aim to evaluate the effectiveness of fibrin sealant patch applied to pancreatico-enteric anastomosis to reduce postoperative complications, including POPF. METHODS This study was a single-center, prospective, randomized, phase IV trial involving three pancreaticobiliary surgeons. The primary outcome was POPF; secondary outcomes included complications, drain removal days, hospital stay, readmission rate, and cost. Risk factors for POPF were identified by logistic regression analysis. RESULTS A total of 124 patients were enrolled. Biochemical leakage (BL) or POPF occurred in 16 patients (25.8%) in the intervention group and 23 patients (37.1%) in the control group (no statistical significance). Clinically relevant POPF occurred in 4 patients (6.5%) in both the intervention and control groups (p = 1.000). Hospital stay (11.6 days vs. 12.1 days, p = 0.585) and drain removal days (5.7 days vs. 5.3 days, p = 0.281) were not statistically different between two groups. Complication rates were not different between the two groups (p = 0.506); nor were readmission rates (12.9% vs. 11.3%, p = 1.000) or cost ($13,549 vs. $15,038, p = 0.103). In multivariable analysis, age and soft pancreas texture were independent risk factors for BL or POPF in this study. Applying fibrin sealant patch is not a negative risk factor, but the p value may indicate a likelihood of reducing the incidence of BL (p = 0.084). CONCLUSIONS Fibrin sealant patches after pancreaticojejunostomy did not reduce the incidence of POPF or other postoperative complications. This study was registered at clinicaltrials.gov (NCT03269955).

Abstract

BACKGROUND The aim of this study was to compare the efficacy, safety and achievement of the target hemoglobin level (Hb >or=10 g/dl) in patients with preoperative anemia due to menorrhagia who received intravenous iron sucrose compared with oral iron protein succinylate for anemia management. METHODS Seventy-six patients with Hb levels <9. 0 g/dl who were scheduled to undergo surgical treatment were randomized to receive either intravenous iron sucrose (based on the calculated total iron deficit divided into 2 ampoule infusions intravenously 3 times a week, beginning 3 weeks before surgery) or oral iron (80 mg/day of oral iron protein succinylate daily). RESULTS The intravenous iron group had higher increases in Hb (3. 0 vs. 0. 8 g/dl; p < 0. 0001) and ferritin levels (170. 1 vs. 4. 1 microg/l; p < 0. 0001) than the oral iron group. Achieving the target Hb was also higher in the intravenous iron group than in the oral iron group (76. 7 vs. 11. 5%; p < 0. 0001). There were tolerable adverse events in both groups. CONCLUSION Preoperative intravenous iron sucrose administration is more effective than oral iron and is as safe as oral iron therapy in the correction of preoperative anemia due to menorrhagia.