Perioperative Synbiotics Decrease Postoperative Complications in Periampullary Neoplasms: A Randomized, Double-Blind Clinical Trial

Abstract

Periampullary neoplasms are rapidly progressive tumors with a poor prognosis and high morbidity and mortality rates, which have a negative influence on patient outcomes. Some probiotics and prebiotics have the ability to protect the intestinal barrier and prevent bacterial translocation, infection, and postoperative complications. We evaluated the use of synbiotics in a prospective, double-blind study of patients undergoing surgery for periampullary neoplasms (PNs) and assessed the effect of these agents on nutritional status, postoperative complications, antibiotic use, length of hospital stay, and mortality. Patients were randomized to receive probiotics and prebiotics–synbiotics—group S [Lactobacillus acidophilus 10, 1 × 10⁹CFU, Lactobacillus rhamnosus HS 111, 1 × 10⁹ CFU, Lactobacillus casei 10, 1 × 10⁹ CFU, Bifidobacterium bifidum, 1 × 10⁹CFU, and fructooligosaccharides (FOS) 100 mg]—or placebo–controls—group C, twice daily, for a total of 14 days. Risk, clinical status, and postoperative complication rates were assessed. Twenty-three patients were allocated to each group. The incidence of postoperative infection was significantly lower in group S (6 of 23 patients, 26.1%) than in group C (16 of 23 patients, 69.6%) (P= 0.00). Duration of antibiotic therapy was also shorter in group S (mean = 9 days vs. 15 days in group C; P= 0.01). Noninfectious complications were less common in group S (6 of 23 vs. 14 of 23 patients in group C; P= 0.03). Mean length of hospital stay was 12 ± 5 days in group S vs. 23±14 days in group C (P= 0.00). No deaths occurred in group S, whereas 6 deaths occurred in group C (P= 0.02). Perioperative administration of synbiotics reduces postoperative mortality and complication rates in patients undergoing surgery for PNs.

Trial registration: ClinicalTrials.gov identifier: NCT01468779.

Funding

This work was partially supported by CNPq/Rede Genoprot (Grant #559814/2009-7), FIPE, Hospital de Clínicas de Porto Alegre (Grant #09256). Alessandro Bersch Osvaldt is investigator of National Counsel of Technological and Scientific Development. Heloisa Martins Sommacal received a grant from the National Coordination for Improvement of Higher Education Personnel.