Assessment of Hemostatic Powder in Order to Prevent Staple Line Bleeding After Sleeve Gastrectomy in High-Risk Patients: A Multicentric Randomized Controlled Trial.

Abstract

Introduction: Preventing staple line bleeding (SLB) is still a main issue in bariatric surgery procedures, especially after laparoscopic sleeve gastrectomy (LSG). Staple line reinforcements (SLR), mattress sutures, or titanium clip application did not show any statistical superiority compared to other methods. In this randomized controlled trial, we tested hemostatic powder (HP) in order to assess a possible role in the prevention of active bleeding, hematoma formation, the need for transfusions, and the increased risk for hospitalization.

Materials and methods: Centers involved started the enrollment of patients from September 2023 to August 2024. Two groups of 96 and 98 patients were created after randomization and application of the inclusion and exclusion criteria. Patients in the first group underwent LSG with application of HP, while the second group went with standard hemostasis with bipolar coagulation and titanium clip application.

Results: There was no difference between the two groups. Overall bleeding was found to be similar between the two groups (p=1.00). Diffuse bleeding was superior in group 2 (p=0.02), while large hematoma formation was superior in group 1 (p=0.02).

Conclusion: The use of HaemoCer™ (BioCer Entwicklungs, GmbH, Bayreuth, Germany) does not reduce staple line bleeding but helps reduce the incidence of hemoperitoneum as well as the reoperation rate, even though hospitalization was similar between the two groups.