|- candidate number||18298|
|- NTR Number||NTR4670|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-jul-2014|
|- Secondary IDs||NL45640.060.13; NCT02175979; M13-1348; 837001505 CCMO; Clinicaltrials.gov; METC; ZonMw|
|- Public Title||Stimuleren van het onwillekeurige zenuwstelsel met perioperatieve voeding bij patiŽnten die een darmoperatie ondergaan.|
|- Scientific Title||Stimulation of the Autonomic Nervous System in Colorectal Surgery by perioperative nutrition|
|- ACRONYM||SANICS II|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Post-operative complications, Anastomotic leakage, Anastomotic Leakage, Colorectal surgery, Postoperative ileus, Intestinal damage, Inflammation, Enteral nutrition|
|- Inclusion criteria||1. Elective segmental colorectal resection with primary anastomosis |
2. Written informed consent
3. Age >18 years
|- Exclusion criteria||1. Previous gastric or oesophageal resection|
2. Pre-existent or creation of ileostoma
3. Steroid use
4. Use of medication that disrupts acetylcholine metabolism (SSRIís or anticonvulsants)
5. Peritoneal metastases
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||10-jul-2014|
|- planned closingdate||31-aug-2017|
|- Target number of participants||280|
|- Interventions||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.
|- Primary outcome||1. Postoperative ileus|
2. Anastomotic leakage
|- Secondary outcome||1. Aspiration pneumonia|
2. Preoperative gastric volumes
3. Length of functional recovery
4. Length of stay
5. The local and systemic inflammatory response
6. Intestinal barrier integrity
7. Surgical complications according to Clavien-Dindo
8. Need for additional surgical, radiological or endoscopic interventions
9. Need for ICU admission and total length of ICU stay
10. Health related quality of life
|- Timepoints||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
|- Trial web site||www.sanics2.nl|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD E.G. Peters|
|- CONTACT for SCIENTIFIC QUERIES|| Misha Luyer|
|- Sponsor/Initiator ||Catharina Hospital Eindhoven|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Danone Research B.V. , Fonds Nuts-Ohra|
|- Brief summary||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.
|- Main changes (audit trail)||12-dec-2014: Changes in endpoints: |
- Primary endpoint "Anastomotic leakage" changed into a secondary endpoint.
- Addition of another secondary endpoint: "Cost effectiveness ratios".
|- RECORD||7-jul-2014 - 28-apr-2017|