SANICS II Trial: Stimulation of the Autonomic Nervous System in Colorectal Surgery by Perioperative Nutrition

NCT02175979 | Completed Results DMC

• 1 other identifier: NL45640.060.13
• Study Type: interventional
• Target: 280
• Locations: 2 countries
• Sites: 5

Brief Summary

The main objective is to investigate the effects of perioperative nutrition on postoperative ileus and anastomotic leakage in patients undergoing colorectal surgery. Perioperative enteral nutrition is compared to the standard of care (fasting perioperatively).

Conditions

Postoperative Ileus; Anastomotic Leak

Keywords

postoperative ileus; anastomotic leak; colorectal surgery; inflammation

Outcome Measures

Primary Outcomes (1)

• Number of Patients Developing Postoperative Ileus

  number of patients with absence of flatus or stool passage and inability to tolerate a regular oral diet between surgery and postoperative day 4

  up to 3 weeks after surgery

Secondary Outcomes (8)

• Anastomotic Leakage

  up to 6 weeks after surgery

• Aspiration Pneumonia

  up to 3 week after surgery

• Gastric Motility

  3 days after surgery

• Functional Recovery

  up to 6 weeks after surgery

• C-reactive Protein (CRP)

  up to 48 hours after surgery

Study Arms (2)

standard

PLACEBO COMPARATOR

standard of care

Dietary Supplement: standard

enriched enteral nutrition

EXPERIMENTAL

enriched enteral tube feeding 1.5ml/ minute perioperative

Dietary Supplement: enriched enteral nutrition

Interventions

enriched enteral nutrition DIETARY_SUPPLEMENT

enriched enteral tube feeding perioperative

enriched enteral nutrition

standard DIETARY_SUPPLEMENT

standard of care

standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients that undergo elective surgical resection of the colon or rectum with primary anastomosis.
• written informed consent
• age \>18 years

You may not qualify if:

• use of medication that disrupts acetylcholine metabolism
• steroid use
• previous gastric or esophageal resection
• peritoneal metastases found during surgery
• ileostomy

Sponsors & Collaborators

• Misha D.P. Luyer: lead
• Danone Global Research & Innovation Center: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Fonds NutsOhra: collaborator

Study Sites (5)

Regionshospitalet Randers

Randers, 8930, Denmark

Location

Regionshospitalet Viborg

Viborg, 8800, Denmark

Location

Catharina Ziekenhuis

Eindhoven, North Brabant, 5623EJ, Netherlands

Location

Maxima Medical Center

Veldhoven, North Brabant, 5504DB, Netherlands

Location

Elkerliek Ziekenhuis

Helmond, 5707HA, Netherlands

Location

Related Publications (11)

• Lubbers T, Luyer MD, de Haan JJ, Hadfoune M, Buurman WA, Greve JW. Lipid-rich enteral nutrition reduces postoperative ileus in rats via activation of cholecystokinin-receptors. Ann Surg. 2009 Mar;249(3):481-7. doi: 10.1097/SLA.0b013e318194d187.

  PMID: 19247038 BACKGROUND

• Luyer MD, Greve JW, Hadfoune M, Jacobs JA, Dejong CH, Buurman WA. Nutritional stimulation of cholecystokinin receptors inhibits inflammation via the vagus nerve. J Exp Med. 2005 Oct 17;202(8):1023-9. doi: 10.1084/jem.20042397. Epub 2005 Oct 10.

  PMID: 16216887 BACKGROUND

• Boelens PG, Heesakkers FF, Luyer MD, van Barneveld KW, de Hingh IH, Nieuwenhuijzen GA, Roos AN, Rutten HJ. Reduction of postoperative ileus by early enteral nutrition in patients undergoing major rectal surgery: prospective, randomized, controlled trial. Ann Surg. 2014 Apr;259(4):649-55. doi: 10.1097/SLA.0000000000000288.

  PMID: 24169163 BACKGROUND

• Lubbers T, Kox M, de Haan JJ, Greve JW, Pompe JC, Ramakers BP, Pickkers P, Buurman WA. Continuous administration of enteral lipid- and protein-rich nutrition limits inflammation in a human endotoxemia model. Crit Care Med. 2013 May;41(5):1258-65. doi: 10.1097/CCM.0b013e31827c0a17.

  PMID: 23388517 BACKGROUND

• Luyer MD, Habes Q, van Hak R, Buurman W. Nutritional stimulation of the autonomic nervous system. World J Gastroenterol. 2011 Sep 14;17(34):3859-63. doi: 10.3748/wjg.v17.i34.3859.

  PMID: 22025873 BACKGROUND

• Luyer MD, Derikx JP, Beyaert R, Hadfoune M, van Kuppevelt TH, Dejong CH, Heineman E, Buurman WA, Greve JW. High-fat nutrition reduces hepatic damage following exposure to bacterial DNA and hemorrhagic shock. J Hepatol. 2009 Feb;50(2):342-50. doi: 10.1016/j.jhep.2008.08.025. Epub 2008 Nov 8.

  PMID: 19070388 BACKGROUND

• Luyer MD, Buurman WA, Hadfoune M, Jacobs JA, Dejong CH, Greve JW. High-fat enteral nutrition reduces endotoxin, tumor necrosis factor-alpha and gut permeability in bile duct-ligated rats subjected to hemorrhagic shock. J Hepatol. 2004 Sep;41(3):377-83. doi: 10.1016/j.jhep.2004.04.026.

  PMID: 15336439 BACKGROUND

• Luyer MD, Jacobs JA, Vreugdenhil AC, Hadfoune M, Dejong CH, Buurman WA, Greve JW. Enteral administration of high-fat nutrition before and directly after hemorrhagic shock reduces endotoxemia and bacterial translocation. Ann Surg. 2004 Feb;239(2):257-64. doi: 10.1097/01.sla.0000108695.60059.80.

  PMID: 14745335 BACKGROUND

• Peters EG, Smeets BJJ, Nors J, Back CM, Funder JA, Sommer T, Laurberg S, Love US, Leclercq WKG, Slooter GD, de Vries Reilingh TS, Wegdam JA, Nieuwenhuijzen GAP, Hiligsmann M, Buise MP, Buurman WA, de Jonge WJ, Rutten HJT, Luyer MDP. Perioperative lipid-enriched enteral nutrition versus standard care in patients undergoing elective colorectal surgery (SANICS II): a multicentre, double-blind, randomised controlled trial. Lancet Gastroenterol Hepatol. 2018 Apr;3(4):242-251. doi: 10.1016/S2468-1253(18)30031-1. Epub 2018 Feb 14.

  PMID: 29426699 DERIVED

• Peters EG, De Jonge WJ, Smeets BJ, Luyer MD. The contribution of mast cells to postoperative ileus in experimental and clinical studies. Neurogastroenterol Motil. 2015 Jun;27(6):743-9. doi: 10.1111/nmo.12579.

  PMID: 26011782 DERIVED

• Peters EG, Smeets BJ, Dekkers M, Buise MD, de Jonge WJ, Slooter GD, Reilingh TS, Wegdam JA, Nieuwenhuijzen GA, Rutten HJ, de Hingh IH, Hiligsmann M, Buurman WA, Luyer MD. 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. Trials. 2015 Jan 27;16:20. doi: 10.1186/s13063-014-0532-x.

  PMID: 25623276 DERIVED

MeSH Terms

Conditions

Anastomotic Leak; Inflammation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: dr Misha Luyer
• Organization: Catharina Hospital

misha.luyer@catharinaziekenhuis.nl

+31402399111

Study Officials

• Misha DP Luyer, MD PhD

  Catharina Ziekenhuis Eindhoven

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: dr. M.D.P. Luyer

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: June 26, 2014
• Study Start: August 1, 2014
• Primary Completion: March 20, 2017
• Study Completion: December 31, 2017
• Last Updated: September 19, 2019
• Results First Posted: September 19, 2019

Record last verified: 2019-08

Locations

DK (2); NL (3)