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

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ClinicalTrials.gov Identifier: NCT02175979
Recruitment Status : Completed
First Posted : June 26, 2014
Results First Posted : September 19, 2019
Last Update Posted : September 19, 2019
Sponsor:
Collaborators:
Danone Research
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ZonMw: The Netherlands Organisation for Health Research and Development
Fonds NutsOhra
Information provided by (Responsible Party):
Misha D.P. Luyer, Catharina Ziekenhuis Eindhoven

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).


Condition or disease Intervention/treatment Phase
Postoperative Ileus Anastomotic Leak Dietary Supplement: enriched enteral nutrition Dietary Supplement: standard Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SANICS II Trial: A Multicenter Prospective Double-blind Randomized Controlled Trial Investigating the Effect of Stimulation of the Autonomic Nervous System in Colorectal Surgery by Perioperative Nutrition
Study Start Date : August 2014
Actual Primary Completion Date : March 20, 2017
Actual Study Completion Date : December 31, 2017

Arm Intervention/treatment
Placebo Comparator: standard
standard of care
Dietary Supplement: standard
standard of care

Experimental: enriched enteral nutrition
enriched enteral tube feeding 1.5ml/ minute perioperative
Dietary Supplement: enriched enteral nutrition
enriched enteral tube feeding perioperative




Primary Outcome Measures :
  1. Number of Patients Developing Postoperative Ileus [ Time Frame: up to 3 weeks after surgery ]
    number of patients with absence of flatus or stool passage and inability to tolerate a regular oral diet between surgery and postoperative day 4


Secondary Outcome Measures :
  1. Anastomotic Leakage [ Time Frame: up to 6 weeks after surgery ]
    number of patients developing anastomotic leakage

  2. Aspiration Pneumonia [ Time Frame: up to 3 week after surgery ]
    number of patients developing aspiration pneumonia

  3. Gastric Motility [ Time Frame: 3 days after surgery ]
    Percent change in Gastric Antral Area, assessed by Ultrasound of the Gastric Antrum Following a Standardized Meal

  4. Functional Recovery [ Time Frame: up to 6 weeks after surgery ]
    Length of functional recovery in days, Functional recovery was defined as postoperative patients not receiving intravenous fluid who have adequate pain control, restoration ofindependent mobility, sufficient caloric intake, and no signs of active infection

  5. C-reactive Protein (CRP) [ Time Frame: up to 48 hours after surgery ]
    the inflammatory response measured systemically (in blood): C-reactive protein (CRP)

  6. Number of Patients Needing Additional Surgical, Radiological or Endoscopic Interventions [ Time Frame: up to 6 weeks after surgery ]
    number of patients needing additional surgical, radiological or endoscopic interventions: All surgical complications are classified using the Clavien-Dindo classification. patients with a Clavien Dindo grade IIIa, IIIb, IVa, IVb, V complication had a surgical, radiological or endoscopic intervention.

  7. Number of Patients Needing ICU Admission [ Time Frame: up to 6 weeks after surgery ]
    number of patients needing ICU admission after surgery

  8. Health-related Quality of Life [ Time Frame: 6 months after surgery ]
    Global Quality of life on a scale ranging from 0 to 100, with higher scores indicating higher level of functioning. The EORTC QLQ C-30 questionnaires are used



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175979


Locations
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Denmark
Regionshospitalet Randers
Randers, Denmark, 8930
Regionshospitalet Viborg
Viborg, Denmark, 8800
Netherlands
Catharina Ziekenhuis
Eindhoven, Noord-Brabant, Netherlands, 5623EJ
Maxima Medical Center
Veldhoven, Noord-Brabant, Netherlands, 5504DB
Elkerliek Ziekenhuis
Helmond, Netherlands, 5707HA
Sponsors and Collaborators
Misha D.P. Luyer
Danone Research
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ZonMw: The Netherlands Organisation for Health Research and Development
Fonds NutsOhra
Investigators
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Principal Investigator: Misha DP Luyer, MD PhD Catharina Ziekenhuis Eindhoven
  Study Documents (Full-Text)

Documents provided by Misha D.P. Luyer, Catharina Ziekenhuis Eindhoven:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Misha D.P. Luyer, dr. M.D.P. Luyer, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT02175979     History of Changes
Other Study ID Numbers: NL45640.060.13
First Posted: June 26, 2014    Key Record Dates
Results First Posted: September 19, 2019
Last Update Posted: September 19, 2019
Last Verified: August 2019
Keywords provided by Misha D.P. Luyer, Catharina Ziekenhuis Eindhoven:
postoperative ileus
anastomotic leak
colorectal surgery
inflammation
Additional relevant MeSH terms:
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Anastomotic Leak
Postoperative Complications
Pathologic Processes