The effects of stimulation of the autonomic nervous system via perioperative nutrition on postoperative ileus and anastomotic leakage following colorectal surgery (SANICS II trial): a study protocol for a double-blind randomized controlled trial

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• 作者：Emmeline G Peters (1) (2)
  Boudewijn JJ Smeets (1)
  Marloes Dekkers (1)
  Marc D Buise (3)
  Wouter J de Jonge (2)
  Gerrit D Slooter (4)
  Tammo S de Vries Reilingh (5)
  Johannes A Wegdam (5)
  Grard AP Nieuwenhuijzen (1)
  Harm JT Rutten (1)
  Ignace HJT de Hingh (1)
  Mickael Hiligsmann (6)
  Wim A Buurman (7)
  Misha DP Luyer (1)
  
  1. Department of Surgery ; Catharina Hospital ; Michelangelolaan 2 ; 5623 EJ ; Eindhoven ; The Netherlands
  2. Academic Medical Center ; Tytgat Institute for Intestinal and Liver Research ; Department of Gastroenterology ; Meibergdreef 69-71 ; 1105 BK ; Amsterdam ; The Netherlands
  3. Department of Anesthesiology ; Catharina Hospital ; Michelangelolaan 2 ; 5623 EJ ; Eindhoven ; The Netherlands
  4. Department of Surgery ; Maxima Medical Center ; De Run 4600 ; 5504 DB ; Veldhoven ; The Netherlands
  5. Department of Surgery ; Elkerliek Hospital ; Wesselmanlaan 25 ; 5707 HA ; Helmond ; The Netherlands
  6. Department of Health Services Research ; Maastricht University ; Duboisdomein 30 ; 6229 GT ; Maastricht ; The Netherlands
  7. Institute MHeNS ; Maastricht University ; PO Box 616 ; 6200 MD ; Maastricht ; The Netherlands
  
• 关键词：Perioperative nutrition ; Colorectal surgery ; Postoperative ileus ; Anastomotic leakage ; Autonomic nervous system ; Inflammation
• 刊名：Trials
• 出版年：2015
• 出版时间：December 2015
• 年：2015
• 卷：16
• 期：1
• 全文大小：541 KB
• 参考文献：1. Spanjersberg WR, Reurings J, Keus F, van Laarhoven CJ. Fast track surgery versus conventional recovery strategies for colorectal surgery. Cochrane Database Syst Rev. 2011;2, CD007635.
  2. Zhuang CL, Ye XZ, Zhang XD, Chen BC, Yu Z. Enhanced recovery after surgery programs versus traditional care for colorectal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2013;56(5):667鈥?8. 42" target="_blank" title="It opens in new window">CrossRef
  3. Kalff JC, Schraut WH, Simmons RL, Bauer AJ. Surgical manipulation of the gut elicits an intestinal muscularis inflammatory response resulting in postsurgical ileus. Ann Surg. 1998;228(5):652鈥?3. 4" target="_blank" title="It opens in new window">CrossRef
  4. Boeckxstaens GE, de Jonge WJ. Neuroimmune mechanisms in postoperative ileus. Gut. 2009;58(9):1300鈥?1. CrossRef
  5. Luyer MD, Buurman WA, Hadfoune M, Jacobs JA, Konstantinov SR, Dejong CH, et al. Pretreatment with high-fat enteral nutrition reduces endotoxin and tumor necrosis factor-alpha and preserves gut barrier function early after hemorrhagic shock. Shock. 2004;21(1):65鈥?1. 49265.cf" target="_blank" title="It opens in new window">CrossRef
  6. Luyer MD, Buurman WA, Hadfoune M, Jacobs JA, Dejong CH, Greve JW. High-fat enteral nutrition reduces endotoxin, tumor necrosis factor-alpha and gut permeability in bile duct-ligated rats subjected to hemorrhagic shock. J Hepatol. 2004;41(3):377鈥?3. 4.04.026" target="_blank" title="It opens in new window">CrossRef
  7. Lubbers T, de Haan JJ, Luyer MD, Verbaeys I, Hadfoune M, Dejong CH, et al. Cholecystokinin/Cholecystokinin-1 receptor-mediated peripheral activation of the afferent vagus by enteral nutrients attenuates inflammation in rats. Ann Surg. 2010;252(2):376鈥?2. 411" target="_blank" title="It opens in new window">CrossRef
  8. Luyer MD, Greve JW, Hadfoune M, Jacobs JA, Dejong CH, Buurman WA. Nutritional stimulation of cholecystokinin receptors inhibits inflammation via the vagus nerve. J Exp Med. 2005;202(8):1023鈥?. 4/jem.20042397" target="_blank" title="It opens in new window">CrossRef
  9. Lubbers T, Kox M, de Haan JJ, Greve JW, Pompe JC, Ramakers BP, et al. Continuous administration of enteral lipid- and protein-rich nutrition limits inflammation in a human endotoxemia model. Crit Care Med. 2013;41(5):1258鈥?5. CrossRef
  10. de Jonge WJ, van der Zanden EP, The FO, Bijlsma MF, van Westerloo DJ, Bennink RJ, et al. Stimulation of the vagus nerve attenuates macrophage activation by activating the Jak2-STAT3 signaling pathway. Nat Immunol. 2005;6(8):844鈥?1. CrossRef
  11. Wang H, Yu M, Ochani M, Amella CA, Tanovic M, Susarla S, et al. Nicotinic acetylcholine receptor alpha7 subunit is an essential regulator of inflammation. Nature. 2003;421(6921):384鈥?. CrossRef
  12. Boelens PG, Heesakkers FF, Luyer MD, van Barneveld KW, de Hingh IH, Nieuwenhuijzen GA, et al. Reduction of postoperative ileus by early enteral nutrition in patients undergoing major rectal surgery: prospective, randomized, controlled trial. Ann Surg. 2014;259(4):649鈥?5. CrossRef
  13. van den Heijkant TC, Costes LMM, van der Lee DGC, Aerts B, Osinga-de Jong M, Rutten HJT, et al. Randomized clinical trial on the effect of gum chewing on postoperative ileus and inflammation in colorectal surgery. Br J Surg / . 2014. doi: 10.1002/bjs.9691.
  14. Mirnezami A, Mirnezami R, Chandrakumaran K, Sasapu K, Sagar P, Finan P. Increased local recurrence and reduced survival from colorectal cancer following anastomotic leak: systematic review and meta-analysis. Ann Surg. 2011;253(5):890鈥?. CrossRef
  15. Vather R, Trivedi S, Bissett I. Defining postoperative ileus: results of a systematic review and global survey. J Gastrointest Surg. 2013;17(5):962鈥?2. 48-y" target="_blank" title="It opens in new window">CrossRef
  16. Darwiche G, Bjorgell O, Thorsson O, Almer LO. Correlation between simultaneous scintigraphic and ultrasonographic measurement of gastric emptying in patients with type 1 diabetes mellitus. J Ultrasound Med. 2003;22(5):459鈥?6.
  17. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240(2):205鈥?3. 4934.ae" target="_blank" title="It opens in new window">CrossRef
  18. Ashraf SQ, Burns EM, Jani A, Altman S, Young JD, Cunningham C, et al. The economic impact of anastomotic leakage after anterior resections in English NHS hospitals: are we adequately remunerating them? Colorectal Dis. 2013;15(4):e190鈥?. CrossRef
  19. Iyer S, Saunders WB, Stemkowski S. Economic burden of postoperative ileus associated with colectomy in the United States. J Manag Care Pharm. 2009;15(6):485鈥?4.
  20. Gooiker GA, Dekker JW, Bastiaannet E, van der Geest LG, Merkus JW, van de Velde CJ, et al. Risk factors for excess mortality in the first year after curative surgery for colorectal cancer. Ann Surg Oncol. 2012;19(8):2428鈥?4. 45/s10434-012-2294-6" target="_blank" title="It opens in new window">CrossRef
  21. Story SK, Chamberlain RS. A comprehensive review of evidence-based strategies to prevent and treat postoperative ileus. Dig Surg. 2009;26(4):265鈥?5. CrossRef
  22. Ishimura K, Moroguchi A, Okano K, Maeba T, Maeta H. Local expression of tumor necrosis factor-alpha and interleukin-10 on wound healing of intestinal anastomosis during endotoxemia in mice. J Surg Res. 2002;108(1):91鈥?. CrossRef
  23. Cerantola Y, Hubner M, Grass F, Demartines N, Schafer M. Immunonutrition in gastrointestinal surgery. Br J Surg. 2011;98(1):37鈥?8. CrossRef
  
• 刊物主题：Medicine/Public Health, general; Biomedicine general; Statistics for Life Sciences, Medicine, Health Sciences;
• 出版者：BioMed Central
• ISSN：1745-6215

文摘

Background Postoperative ileus and anastomotic leakage are important complications following colorectal surgery associated with short-term morbidity and mortality. Previous experimental and preclinical studies have shown that a short intervention with enriched enteral nutrition dampens inflammation via stimulation of the autonomic nervous system and thereby reduces postoperative ileus. Furthermore, early administration of enteral nutrition reduced anastomotic leakage. This study will investigate the effect of nutritional stimulation of the autonomic nervous system just before, during and early after colorectal surgery on inflammation, postoperative ileus and anastomotic leakage. Methods/Design This multicenter, prospective, double-blind, randomized controlled trial will include 280 patients undergoing colorectal surgery. All patients will receive a selfmigrating nasojejunal tube that will be connected to a specially designed blinded tubing system. Patients will be allocated either to the intervention group, receiving perioperative nutrition, or to the control group, receiving no nutrition. The primary endpoint is postoperative ileus. Secondary endpoints include anastomotic leakage, local and systemic inflammation, (aspiration) pneumonia, surgical complications classified according to Clavien-Dindo, quality of life, gut barrier integrity and time until functional recovery. Furthermore, a cost-effectiveness analysis will be performed. Discussion Activation of the autonomic nervous system via perioperative enteral feeding is expected to dampen the local and systemic inflammatory response. Consequently, postoperative ileus will be reduced as well as anastomotic leakage. The present study is the first to investigate the effects of enriched nutrition given shortly before, during and after surgery in a clinical setting. Trial registration ClinicalTrials.gov: NCT02175979 - date of registration: 25 June 2014. Dutch Trial Registry: NTR4670 - date of registration: 1 August 2014.