Shunichiro Komatsu1, Eiji Sakamoto2, Shinji Norimizu2, Yuji Shingu2, Takashi Asahara3, Koji Nomoto3, Masato Nagino4. 1. Department of Gastroenterological Surgery, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan. skomat2718@gmail.com. 2. Department of Digestive Surgery, Nagoya Daini Red Cross Hospital, Nagoya, Japan. 3. Yakult Central Institute, Tokyo, Japan. 4. Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Abstract
PURPOSE: The aim of this study was to assess the effect of perioperative oral administration of synbiotics on the surgical outcome in patients undergoing laparoscopic colorectal resection. METHODS: In this single-center randomized, controlled trial, patients scheduled to undergo elective laparoscopic colorectal surgery were eligible to participate and randomly assigned to a synbiotics group or a control group. The primary study outcome was the development of infectious complications, particularly surgical site infection (SSI), within 30 days of surgery. RESULTS: In this study, 379 patients were enrolled and randomly assigned (173 to the synbiotics group and 206 to the control group), of whom 362 patients (168 to the synbiotics group and 194 to the control group) were eligible for this study. SSI occurred in 29 (17.3%) patients in the synbiotics group and 44 (22.7%) patients in the control group (OR: 0.761, 95% CI 0.50-1.16; p = 0.20). Overall, the rate of postoperative complications, including anastomotic leakage, did not differ significantly between the two groups. Synbiotics treatment reversed the changes in fecal bacteria and organic acids after surgery and suppressed the increases in potentially pathogenic species, such as Clostridium difficile. CONCLUSION: The efficacy of perioperative administration of synbiotics was not validated as a treatment for reducing the incidence of infectious complicationsafter laparoscopic colorectal resection. However, the microbial imbalance, in addition to the reduction in organic acids, could be improved by perioperative synbiotics treatment.
RCT Entities:
PURPOSE: The aim of this study was to assess the effect of perioperative oral administration of synbiotics on the surgical outcome in patients undergoing laparoscopic colorectal resection. METHODS: In this single-center randomized, controlled trial, patients scheduled to undergo elective laparoscopic colorectal surgery were eligible to participate and randomly assigned to a synbiotics group or a control group. The primary study outcome was the development of infectious complications, particularly surgical site infection (SSI), within 30 days of surgery. RESULTS: In this study, 379 patients were enrolled and randomly assigned (173 to the synbiotics group and 206 to the control group), of whom 362 patients (168 to the synbiotics group and 194 to the control group) were eligible for this study. SSI occurred in 29 (17.3%) patients in the synbiotics group and 44 (22.7%) patients in the control group (OR: 0.761, 95% CI 0.50-1.16; p = 0.20). Overall, the rate of postoperative complications, including anastomotic leakage, did not differ significantly between the two groups. Synbiotics treatment reversed the changes in fecal bacteria and organic acids after surgery and suppressed the increases in potentially pathogenic species, such as Clostridium difficile. CONCLUSION: The efficacy of perioperative administration of synbiotics was not validated as a treatment for reducing the incidence of infectious complications after laparoscopic colorectal resection. However, the microbial imbalance, in addition to the reduction in organic acids, could be improved by perioperative synbiotics treatment.
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