Gideon Sroka1, Daria Milevski, Dan Shteinberg, Husam Mady, Ibrahim Matter. 1. Department of General Surgery, Bariatric Surgery Service, Bnai-Zion Medical Center, Faculty of Medicine, Technion - Israel Institute of Technology, 47 Golomb St., Haifa, Israel, gideon.sroka@gmail.com.
Abstract
BACKGROUND:Laparoscopic sleeve gastrectomy (LSG) has gained worldwide popularity in recent years. Hemorrhagic complications (HC) are usually the result of stapler line bleeding and are probably underreported. The previous incidence of HC in our department including minor bleeding and late hematomas was 15.0 %. The objective of this study is to assess the impact of stapler line reinforcement (SLR) and intraoperative blood pressure control on HC after LSG. METHODS:Between February 2013 and March 2014, patients who were admitted to our department for LSG were randomly assigned to one of three arms: stapler line application of biologic glue--Evicel™ (E), over suture of the stapler line (S) or control (C). Surgical technique in all arms included blood pressure elevation to 140 mmHg before termination of the procedure. Data is presented as mean ± SD or median (IQR 25-75). RESULTS:One hundred sixty-five patients were randomized: 49 to E, 49 to S, and 67 to C. There were no demographic differences between arms. Operative time was significantly longer in S than in E and C arms (74 ± 21 vs. 64 ± 23 and 54 ± 19 min, respectively). ∆Hb was significantly lower in the S group. Packed cells were used in two from E and one from C arms. Late infected hematoma occurred in three (1.8 %) patients: one from E and two from C arms. Leak rate was 1.2 %: one from S and one from C arms. LOS was the same. No patients were re-operated due to bleeding. CONCLUSIONS: In this randomized trial, routine elevation of systolic blood pressure to 140 mmHg and over suture of the staple line in LSG minimized HC, with reasonable prolongation of the procedure.
RCT Entities:
BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) has gained worldwide popularity in recent years. Hemorrhagic complications (HC) are usually the result of stapler line bleeding and are probably underreported. The previous incidence of HC in our department including minor bleeding and late hematomas was 15.0 %. The objective of this study is to assess the impact of stapler line reinforcement (SLR) and intraoperative blood pressure control on HC after LSG. METHODS: Between February 2013 and March 2014, patients who were admitted to our department for LSG were randomly assigned to one of three arms: stapler line application of biologic glue--Evicel™ (E), over suture of the stapler line (S) or control (C). Surgical technique in all arms included blood pressure elevation to 140 mmHg before termination of the procedure. Data is presented as mean ± SD or median (IQR 25-75). RESULTS: One hundred sixty-five patients were randomized: 49 to E, 49 to S, and 67 to C. There were no demographic differences between arms. Operative time was significantly longer in S than in E and C arms (74 ± 21 vs. 64 ± 23 and 54 ± 19 min, respectively). ∆Hb was significantly lower in the S group. Packed cells were used in two from E and one from C arms. Late infected hematoma occurred in three (1.8 %) patients: one from E and two from C arms. Leak rate was 1.2 %: one from S and one from C arms. LOS was the same. No patients were re-operated due to bleeding. CONCLUSIONS: In this randomized trial, routine elevation of systolic blood pressure to 140 mmHg and over suture of the staple line in LSG minimized HC, with reasonable prolongation of the procedure.