• Lionel Rebibo, Abdennaceur Dhahri, Rachid Chati, Cyril Cosse, Emmanuel Huet, and Jean-Marc Regimbeau.
• Department of Digestive Surgery, Amiens University Hospital, Amiens, France.
• Ann. Surg. 2018 Nov 1; 268 (5): 762-768.

ObjectivesEvaluate the effectiveness of the use of fibrin sealant (FS) for preventing the development of staple line complications (SLCs) after sleeve gastrectomy (SG).BackgroundThere is no consensus on the best means of preventing SLCs after SG.MethodsThis 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 1:1 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.ResultsThere 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.ConclusionThe incidence of postoperative SLCs did not appear to depend on the presence or absence of FS.

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