Peroperative administration of tranexamic acid in sleeve gastrectomy to reduce hemorrhage: a double-blind randomized controlled trial.

"Declarations DisclosuresThe authors JWH‘tHart, BJNoordman, JMAWijnand, LUBiter, SJCV, EB, MD, JH, and JAA declare that they have no conflict of interest or financial ties to disclose. Ethical approvalAll procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study protocol was approved by the IRB and Medical Research Ethics Committees United (MEC-U), Nieuwegein, on July 29, 2019, the Netherlands (Protocol number R19.041). Informed consentInformed consent was obtained from all individual participants included in the study. Disclosures The authors JWH‘tHart, BJNoordman, JMAWijnand, LUBiter, SJCV, EB, MD, JH, and JAA declare that they have no conflict of interest or financial ties to disclose."

"The study protocol has been published previously (supplementary file 1) []. In brief, we conducted a double-blind randomized controlled trial in a high-volume bariatric hospital. At the outpatient clinic, the coordinating researcher recruited all patients with sufficient Dutch or English language proficiency who were planned to undergo primary SG and met the international guidelines for metabolic surgery []. Exclusion criteria were use of anticoagulants, medical history of VTE (defined as deep vein thrombosis or pulmonary embolism) or hemorrhage, and arterial and/or severe iatrogenic bleeding during surgery. Enrollment stopped in September 2021 when the inclusion target for the study was achieved. This study was registered with the Netherlands Trial Register (NL8029)."