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Synbiotics in Surgery for Chronic Pancreatitis: Are They Truly Effective? A Single-blind Prospective Randomized Control Trial

Rammohan, Ashwin FRCS; Sathyanesan, Jeswanth MCh; Rajendran, Kamalakannan MCh; Pitchaimuthu, Anbalagan MCh; Perumal, Senthil Kumar MCh; Balaraman, Kesavan MCh; Ramasamy, Ravi MCh; Palaniappan, Ravichandran MCh; Govindan, Manoharan MCh

doi: 10.1097/SLA.0000000000001077
Randomized Controlled Trials

Background: Postoperative infectious complications in patients undergoing pancreatic surgery are a significant cause for morbidity and mortality. Although synbiotics have beneficial effects on human health, their clinical value in surgical patients remains unclear given a paucity of applicable clinical studies.

Aim: To determine the impact of perioperative synbiotic therapy on postoperative infectious complications, morbidity and mortality in patients undergoing pancreatic surgery for chronic pancreatitis.

Methods: A trial was conducted in patients with chronic calcific pancreatitis undergoing Frey's procedure. Group A received a specific synbiotic composition, 5 days prior and 10 days after the surgery. Group B received a placebo. Primary study endpoint was the occurrence of postoperative infection during the first 30 days. Secondary outcome measures were mortality, length of hospital stay, days in intensive care unit, and duration of antibiotic therapy. Using previously accrued data, with α of 0.05 and power 80%, the sample size was calculated as 35 patients for each group with a dropout rate of 10%.

Results: Of the 79 patients enrolled, 75 completed the trial [group A (n = 39) and group B (n = 36)]. The incidence of postoperative infectious complications (12.8% vs 39%; P < 0.05), duration of antibiotics therapy (P < 0.05), and length of hospital stay (P < 0.05) were significantly lower in the synbiotic group.

Conclusions: Synbiotics significantly reduce septic complications, hospital stay, and antibiotic requirement in patients undergoing pancreatic surgery for chronic pancreatitis. Furthermore, basic and clinical research would clarify the underlying mechanisms of their therapeutic effect and define the appropriate conditions for use.

The study aimed to determine the impact of perioperative synbiotic therapy in patients undergoing surgery for chronic pancreatitis. Results suggest that synbiotics significantly reduce septic complications, hospital stay, and antibiotic requirement.

From the Institute of Surgical Gastroenterology & Liver Transplantation, Centre for GI Bleed, Division of HPB Diseases, Stanley Medical College Hospital, Chennai, India.

Reprints: Ashwin Rammohan, FRCS, Institute of Surgical Gastroenterology & Liver Transplantation, Centre for GI Bleed, Division of HPB Diseases, Stanley Medical College Hospital, Old Jail Rd, Chennai, 600 001, India. E-mail: ashwinrammohan@gmail.com.

This study won the best oral paper award at the 11th World Congress of the International Hepato-Pancreato-Biliary Association (IHPBA), March 22 to 27, 2014, Seoul, South Korea.

Disclosure: No funding of any kind was received for this study. The authors declare no conflicts of interest or financial ties to disclose.

Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.