Abstract
BackgroundPostoperative 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/DesignThis 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.DiscussionActivation 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 registrationClinicalTrials.gov: NCT02175979 - date of registration: 25 June 2014.Dutch Trial Registry: NTR4670 - date of registration: 1 August 2014.
Highlights
Postoperative ileus and anastomotic leakage are important complications following colorectal surgery associated with short-term morbidity and mortality
Study objectives The objective is to investigate whether enriched enteral nutrition given shortly before, during and early after colorectal surgery, reduces Postoperative ileus (POI) and anastomotic leakage (AL) via stimulation of the autonomic nervous system in a clinical setting, compared with standard care
Despite advances that are being made in surgical technique and improvement in postoperative care, POI and AL remain very important clinical determinants of shortterm morbidity and mortality following colorectal surgery
Summary
Despite advances that are being made in surgical technique and improvement in postoperative care, POI and AL remain very important clinical determinants of shortterm morbidity and mortality following colorectal surgery. In previous experimental and clinical studies our group has shown that a short intervention with enriched enteral nutrition given just before and directly after the inciting event, dampens the inflammatory response and reduces POI by stimulation of the autonomic nervous system through release of CCK. Improvement of postoperative care and reduction of POI and AL is a complex challenge that requires a multidisciplinary approach This clinical study will be performed based on the hypothesis that early modulation of the immune response by enriched enteral nutrition will reduce POI and affect AL. Reduction of POI and AL following colorectal surgery would optimize surgical care for this large patient group and thereby reduce healthcare costs, but may open new therapeutic opportunities and changes the way of thinking about the usage of enteral nutrition in a clinical setting.
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