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World Journal of Surgery

, Volume 39, Issue 11, pp 2776–2783 | Cite as

A Four-Probiotics Regimen Reduces Postoperative Complications After Colorectal Surgery: A Randomized, Double-Blind, Placebo-Controlled Study

  • Katerina KotzampassiEmail author
  • George Stavrou
  • Georgia Damoraki
  • Marianna Georgitsi
  • George Basdanis
  • Georgia Tsaousi
  • Evangelos J. Giamarellos-Bourboulis
Original Scientific Report

Abstract

Background

Heterogeneous results of published studies led to conduct a randomized clinical trial to assess the efficacy of a new formulation of four probiotics as prophylaxis for complications after colorectal surgery.

Methods

A double-blind, placebo-controlled randomized study was conducted enrolling patients undergoing colorectal surgery for cancer. Capsules of placebo or of a formulation containing Lactobacillus acidophilus, L. p lantarum, Bifidobacterium lactis and Saccharomyces boulardii were administered starting one day before operation and continuing for another 15 days postoperatively. Patients were followed up for 30 days with the development of postoperative complications as the primary outcome. Gene expression and serum levels of cytokines were measured on postoperative day 4 (www.clinicaltrials.gov NCT02313519).

Results

The study was prematurely stopped after enrolment due to efficacy in the primary outcome. Administration of probiotics significantly decreased the rate of all postoperative major complication (28.6 vs. 48.8 % of the placebo arm, p 0.010, odds ratio 0.42). Major benefit was found in the reduction of the rate of postoperative pneumonia (2.4 vs. 11.3 %, p 0.029), of surgical site infections (7.1 vs. 20.0 %, p 0.020) and of anastomotic leakage (1.2 vs. 8.8 %, p 0.031). The time until hospital discharge was shortened as well. Gene expression of SOCS3 was positively related with gene expression of TNF and of circulating IL-6 in the probiotic group but not in the placebo group.

Conclusions

The studied probiotic formulation significantly decreased the risk of postoperative complications, namely mechanical ventilation, infections and anastomotic leakage. Modulation of the gene expression of SOCS3 is one suggested mechanism (www.clinicaltrials.gov NCT02313519).

Keywords

Anastomotic Leakage Surgical Site Infection Postoperative Infection Acinetobacter Baumannii Lactobacillus Acidophilus 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgments

Placebo capsules and consumables for laboratory exams were a kind donation by UniPharma, Athens, Greece.

Conflict of interest

None of the authors has any conflict of interest related to this study.

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Copyright information

© Société Internationale de Chirurgie 2015

Authors and Affiliations

  • Katerina Kotzampassi
    • 1
    Email author
  • George Stavrou
    • 1
  • Georgia Damoraki
    • 2
  • Marianna Georgitsi
    • 2
  • George Basdanis
    • 1
  • Georgia Tsaousi
    • 1
  • Evangelos J. Giamarellos-Bourboulis
    • 2
  1. 1.Department of SurgeryAristotle University of Thessaloniki, Medical SchoolThessalonikiGreece
  2. 2.4th Department of Internal MedicineUniversity of Athens, Medical SchoolAthensGreece

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