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document
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 . 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 .
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Intervention_Physical
perioperative nutrition
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Intervention_Surgical
selfmigrating nasojejunal tube
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Intervention_Physical
receiving perioperative nutrition
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Intervention_Other
receiving no nutrition
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Outcome_Physical
postoperative ileus
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Outcome_Physical
anastomotic leakage
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Outcome_Physical
anastomotic leakage
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Outcome_Physical
postoperative ileus
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Outcome_Physical
anastomotic leakage
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Outcome_Physical
local and systemic inflammation
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Outcome_Physical
( aspiration ) pneumonia
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Outcome_Adverse-effects
surgical complications classified according to
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Outcome_Physical
Clavien-Dindo
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Outcome_Physical
quality of life
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Outcome_Physical
gut barrier integrity and time until functional recovery
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Outcome_Physical
local and systemic inflammatory response
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Outcome_Physical
postoperative ileus
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Outcome_Physical
anastomotic leakage
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Participant_Sample-size
280 patients
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Participant_Condition
colorectal surgery