Giving perioperative lipid-enriched nutrition in colorectal surgery stimulates the autonomic nervous system leading to an anti-inflammatory effect. This will lead to a decrease in postoperative ileus and anastomotic leakage.
ID
Bron
Verkorte titel
Aandoening
Postoperative ileus, anastomotic leakage, colorectal surgery, enteral nutrition, intestinal damage, inflammation
Ondersteuning
Danone/Nutricia
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Postoperative ileus<br>
Achtergrond van het onderzoek
Postoperative ileus (POI) and anastomotic leakage (AL) 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 POI. Furthermore, early administration of enteral nutrition after surgery reduced AL. This study investigates the effect of nutritional stimulation of the autonomic nervous system just before, during and after surgery on inflammation, POI and AL.
This multicentre, prospective, double blind, randomised controlled trial will include 280 patients undergoing colorectal surgery. All patients receive a selfmigrating nasojejunal tube that will be connected to a custom-made blinded tubing. Subsequently, patients are allocated to either the intervention group, receiving perioperative nutrition or to the control group, receiving no nutrition. Primary endpoints are POI and AL. Secondary endpoints are local and systemic inflammation, (aspiration) pneumonia, surgical complications classified according to Clavien-Dindo, quality of life, gut barrier integrity and length of functional recovery. Furthermore, a cost-effectiveness analysis will be performed.
Activation of the autonomic nervous system via perioperative enteral feeding is expected to dampen the local and systemic inflammatory response. Consequently, POI will be reduced as well as AL. The present study is the first to investigate the effects of enriched nutrition given shortly before, during and after surgery in a clinical setting.
Doel van het onderzoek
Giving perioperative lipid-enriched nutrition in colorectal surgery stimulates the autonomic nervous system leading to an anti-inflammatory effect. This will lead to a decrease in postoperative ileus and anastomotic leakage.
Onderzoeksopzet
1. Postoperative ileus: within 1 week after surgery by daily control of clinical parameters, and rate of gastric emptying at postoperative day 2.
2. Anastomotic leakage: within 6 weeks after surgery by clinical/radiological signs or confirmed by reoperation.
3. Inflammatory response: bloodsamples: preoperatively, 4-24-48hours postoperatively, tissue sample and peritoneal lavage sample during surgery.
4. Quality of life: preoperatively, 3 months, 6 months
Onderzoeksproduct en/of interventie
All patients receive a selfmigrating nasojejunal tube. Via a custom-made tubing system blinding will be ensured.
Intervention group: patients will receive enriched enteral nutrition from 3 hours prior to surgery, until 6 hours after surgery.
Control group: patients will not receive nutrition, but via the special tubing, the nutrition will be collected in a bedside-container instead.
Algemeen / deelnemers
E.G. Peters
Eindhoven
The Netherlands
+31-40-2396350
emmeline.peters@cze.nl
Wetenschappers
E.G. Peters
Eindhoven
The Netherlands
+31-40-2396350
emmeline.peters@cze.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Elective segmental colorectal resection with primary anastomosis
2. Written informed consent
3. Age >18 years
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Previous gastric or oesophageal resection
2. Pre-existent or creation of ileostoma
3. Steroid use
4. Use of medication that disrupts acetylcholine metabolism (SSRI’s or anticonvulsants)
5. Peritoneal metastases
Opzet
Deelname
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