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Randomized Controlled Trial
Synbiotics in Surgery for Chronic Pancreatitis: Are They Truly Effective? A Single-blind Prospective Randomized Control Trial.
- Ashwin Rammohan, Jeswanth Sathyanesan, Kamalakannan Rajendran, Anbalagan Pitchaimuthu, Senthil Kumar Perumal, Kesavan Balaraman, Ravi Ramasamy, Ravichandran Palaniappan, and Manoharan Govindan.
- From the Institute of Surgical Gastroenterology & Liver Transplantation, Centre for GI Bleed, Division of HPB Diseases, Stanley Medical College Hospital, Chennai, India.
- Ann. Surg.. 2015 Jul 1;262(1):31-7.
BackgroundPostoperative 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.AimTo determine the impact of perioperative synbiotic therapy on postoperative infectious complications, morbidity and mortality in patients undergoing pancreatic surgery for chronic pancreatitis.MethodsA 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%.ResultsOf 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.ConclusionsSynbiotics 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.
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