Sucrosomial® Iron Supplementation during Perioperative Period in General Surgery

Abstract

Anemia frequently occurs in patients undergoing general surgery and in particular for gastrointestinal surgery [1]. The impact of anemia and iron deficiency on abdominal surgery outcomes is well known [1-3] and new preoperative strategies are nowadays considered to improve patient conditions during the perioperative period. Iron supplementation is often administered intravenously, since conventional oral iron therapies are usually less effective [4]. Since Sucrosomial iron, an innovative oral iron formulation where iron is conveyed into a matrix of phospholipids and sucrester, appears to be effective in improving Hb levels and reducing blood transfusion during the perioperative period (5), we aim to determine whether oral Sucrosomial® Iron supplementation enables better results in terms of recovery, length of hospital stay and need of blood transfusions in anemic patients undergoing major elective gastrointestinal surgery.Data from patients scheduled for major gastrointestinal surgery were prospectively collected between October 2016 and July 2017. Supplementation with oral Sucrosomial Iron (1 capsule/day) for 2 to 3 weeks prior to surgery, was recommended to patients, scheduled for colorectal surgery (right and left hemicolectomy, segmental colonic resection or anterior rectal resection) or gastric surgery (total or subtotal gastrectomy), that showed levels of hemoglobin < 13 g/dL for women and < 14 g/dL for men during preoperative visit. The level of hemoglobin was evaluated one week before surgery, during the preoperative follow up visit, and one day after surgery. Moreover, blood transfusion needs and length of hospital stay were also evaluated. Thirty-five patients have been currently enrolled, however 4 patients were excluded due to intraoperative findings of advanced neoplastic disease and 3 due to post-operative anastomotic bleeding. To date, the post-operative results from 10 patients are available and have been analyzed in terms of hemoglobin values, blood transfusions and hospital stay. These preliminary results were compared to an equivalent historical population of 82 patients extrapolated from a pool of patients, who underwent major elective gastrointestinal surgery in 2015. Thus, patients that received palliative intervention and those with hemorrhagic post-operative complications were excluded. The two populations were not pair-matched. This comparable group of patients from 2015 was chosen in order to evaluate the difference in hemoglobin drop recorded after surgery and evaluate a possible preoperative protocol implementation that includes sucrosomial iron supplementation.Preliminary results from patients supplemented with Sucrosomial® iron showed that average hemoglobin levels one week prior to surgery (preOP) were 11.5 ± 1.72 g/dL, which were maintained after surgery (postOP, 11.3 ± 1.45 g/dL). These results showed a smaller decrease in the expected post-operative hemoglobin drop compared to an equivalent and not supplemented population from 2015 (0.2 g/dL vs 1.9 g/dL). Moreover, average blood transfusions decrease of 2 folds to 0.20 ± 0.03 units/patient in patients supplemented with Sucrosomial iron, compare to 2015 patients (0.41 ± 0.07 units/patient). Finally, mean hospital stay appears to be longer in the Sucrosomial iron group, however this result was biased by 2 patients whose longer hospitalization was not due to anemia.Preliminary results show that supplementation with Sucrosomial® iron allows an improvement in perioperative Hb levels and a decrease in blood transfusion compared to a comparable historical population. Thus these finding appear to confirm previous results on Sucrosomial® iron in patients undergoing elective surgery (5). However, these are preliminary results and data collected from all patients still need to be analyzed. Moreover, confirmation on a larger cohort of patients is need.1. Hallet J, et al. Transfus Med Rev. 2014 Oct;28(4):205-11. Review.2. Hogan M, et al. Eur J Cardiothorac Surg. 2015 Feb;47(2):218-26. Review.3. Yohanathan L, et al. J Gastrointest Surg. 2016 Jun;20(6):1106-22.4. Garrido-Martín et al. Interact Cardiovasc Thorac Surg. 2012 Dec;15(6):1013-85. Scardino M. et al. Expert Review of Hematology. 2016;9:1-42. [Display omitted] DisclosuresPera:Pharmanutra S.p.A.: Employment. Tarantino:Pharmanutra S.p.A.: Employment.