The study on the safety and feasibility of gastroenterological surgery in patients undergoing antithrombotic therapy: Study protocol for a multicenter prospective cohort analysis (The GSATT Study)

Abstract

BACKGROUND: Although there are several large-scale single center cohort studies concerning gastroenterological (GE) surgery in patients receiving antithrombotic therapy (ATT), no clear evidence or guidelines based on multicenter prospective studies have not yet been established. The main purpose of this multicenter prospective cohort study is to assess the safety and feasibility of GE surgery in ATT-received patients during the perioperative period. METHODS/DESIGN: This is a multicenter, prospective cohort study conducted in Japan.  Patients receiving antithrombotic therapy (antiplatelet therapy and/or anticoagulation therapy [warfarin or direct oral anticoagulants (DOACs)]), as well as undergoing elective GE surgery (including open surgery, laparoscopic surgery, and robot-assisted surgery) are included in the current study; those undergoing emergency GE surgery are excluded. The primary endpoints include intraoperative factors including surgical blood loss, postoperative hemorrhagic complications, and thromboembolic complications; secondary endpoints include other postoperative complications, presence of re-operation, and the length of postoperative stay. DISCUSSION: The present study can contribute to the determination of the safety and feasibility of elective GE surgery to ATT-received patients and is thought to establish optimal perioperative antithrombotic management for such challenging patient population.