title: 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.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT02175979 - date of registration: 25 June 2014. Dutch Trial Registry: NTR4670 - date of registration: 1 August 2014.
authors.affiliation: Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands. emmeline.peters@cze.nl.|Academic Medical Center, Tytgat Institute for Intestinal and Liver Research, Department of Gastroenterology, Meibergdreef 69-71, 1105 BK, Amsterdam, The Netherlands. emmeline.peters@cze.nl.
authors.forename: Emmeline G
authors.initials: EG
authors.lastname: Peters
authors.affiliation: Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands. boudewijn.smeets@cze.nl.
authors.forename: Boudewijn J J
authors.initials: BJ
authors.lastname: Smeets
authors.affiliation: Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands. dekkers_marloes@hotmail.com.
authors.forename: Marloes
authors.initials: M
authors.lastname: Dekkers
authors.affiliation: Department of Anesthesiology, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands. marc.buise@cze.nl.
authors.forename: Marc D
authors.initials: MD
authors.lastname: Buise
authors.affiliation: Academic Medical Center, Tytgat Institute for Intestinal and Liver Research, Department of Gastroenterology, Meibergdreef 69-71, 1105 BK, Amsterdam, The Netherlands. w.j.dejonge@amc.nl.
authors.forename: Wouter J
authors.initials: WJ
authors.lastname: de Jonge
authors.affiliation: Department of Surgery, Maxima Medical Center, De Run 4600, 5504 DB, Veldhoven, The Netherlands. g.slooter@mmc.nl.
authors.forename: Gerrit D
authors.initials: GD
authors.lastname: Slooter
authors.affiliation: Department of Surgery, Elkerliek Hospital, Wesselmanlaan 25, 5707 HA, Helmond, The Netherlands. tdevriesreilingh@elkerliek.nl.
authors.forename: Tammo S de Vries
authors.initials: TS
authors.lastname: Reilingh
authors.affiliation: Department of Surgery, Elkerliek Hospital, Wesselmanlaan 25, 5707 HA, Helmond, The Netherlands. jwegdam@elkerliek.nl.
authors.forename: Johannes A
authors.initials: JA
authors.lastname: Wegdam
authors.affiliation: Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands. grard.nieuwenhuijzen@cze.nl.
authors.forename: Grard A P
authors.initials: GA
authors.lastname: Nieuwenhuijzen
authors.affiliation: Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands. harm.rutten@cze.nl.
authors.forename: Harm J T
authors.initials: HJ
authors.lastname: Rutten
authors.affiliation: Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands. ignace.d.Hingh@cze.nl.
authors.forename: Ignace H J T
authors.initials: IH
authors.lastname: de Hingh
authors.affiliation: Department of Health Services Research, Maastricht University, Duboisdomein 30, 6229 GT, Maastricht, The Netherlands. m.hiligsmann@maastrichtuniversity.nl.
authors.forename: Mickael
authors.initials: M
authors.lastname: Hiligsmann
authors.affiliation: Institute MHeNS, Maastricht University, PO Box 616, 6200 MD, Maastricht, The Netherlands. w.buurman@maastrichtuniversity.nl.
authors.forename: Wim A
authors.initials: WA
authors.lastname: Buurman
authors.affiliation: Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands. misha.luyer@cze.nl.
authors.forename: Misha D P
authors.initials: MD
authors.lastname: Luyer
mesh_terms: D057868:Anastomotic Leak / Q000517:prevention & control*; D001341:Autonomic Nervous System / Q000502:physiology*; D002985:Clinical Protocols; D003107:Colorectal Surgery / Q000009:adverse effects*; D004311:Double-Blind Method; D004750:Enteral Nutrition; D006801:Humans; D045823:Ileus / Q000517:prevention & control*; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies