Effectiveness of Fibrin Sealant Application on the Development of Staple Line Complications After Sleeve Gastrectomy: A Prospective Randomized Trial.

ABSTRACT

OBJECTIVES: Evaluate the effectiveness of the use of fibrin sealant (FS) for preventing the development of staple line complications (SLCs) after sleeve gastrectomy (SG). BACKGROUND: There is no consensus on the best means of preventing SLCs after SG. METHODS: This was a prospective, intention-to-treat, randomized, 2 center study of a group of 586 patients undergoing primary SG (ClinicalTrials.gov identifier NCT01613664) between March 2014 and June 2017. The 11 randomization was stratified by center, age, sex, gender, and body mass index, giving 293 patients in the FS group and 293 in the control group (without FS). The primary endpoint (composite criteria) was the incidence of SLCs in each of the 2 groups. The secondary criteria were the mortality rate, morbidity rate, reoperation rate, length of hospital stay, readmission rate, and risk factors for SLC. RESULTS: There were no intergroup differences in demographic variables. In an intention-to-treat analysis, the incidence of SLCs was similar in the FS and control groups (1.3% vs 2%, respectively; P = 0.52). All secondary endpoints were similar complication rate (5.4% vs 5.1%, respectively; P = 0.85), mortality rate (0.3% vs 0%, respectively; P = 0.99), GL rate (0.3% vs 1.3%, respectively; P = 0.18), postoperative hemorrhage/hematoma rate (1% vs 0.7%, respectively; P = 0.68), reoperation rate (1% vs 0.3%, respectively; P = 0.32). Length of stay was 1 day in both groups (P = 0.89), and the readmission rate was similar (5.1% vs 3.4%, respectively; P = 0.32). No risk factors for SLCs were found. CONCLUSION: The incidence of postoperative SLCs did not appear to depend on the presence or absence of FS.