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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Postoperative Ileus
Anastomotic Leak
Interventions Dietary Supplement: enriched enteral nutrition
Dietary Supplement: standard
Enrollment 280
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Enriched Enteral Nutrition
Hide Arm/Group Description standard of care enriched enteral tube feeding 1.5ml/ minute perioperative
Period Title: Overall Study
Started 140 140
Completed 133 132
Not Completed 7 8
Arm/Group Title Standard Enriched Enteral Nutrition Total
Hide Arm/Group Description

standard of care

standard: standard of care

enriched enteral tube feeding 1.5ml/ minute perioperative

enriched enteral nutrition: enriched enteral tube feeding perioperative

Total of all reporting groups
Overall Number of Baseline Participants 133 132 265
Hide Baseline Analysis Population Description
in both arms, 140 patients participated. in the standard arm 7 patients had to quit the study because exclusion criteria were met, in the enriched enteral nutrition 8 patients had to quit the study because exclusion criteria were met, which is stated in the results participant flow.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 133 participants 132 participants 265 participants
68
(63 to 74)
69
(62 to 75)
68
(63 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 132 participants 265 participants
Female
55
  41.4%
52
  39.4%
107
  40.4%
Male
78
  58.6%
80
  60.6%
158
  59.6%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Netherlands Number Analyzed 133 participants 132 participants 265 participants
101 103 204
Denmark Number Analyzed 133 participants 132 participants 265 participants
32 29 61
BMI  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 133 participants 132 participants 265 participants
26
(24 to 29.3)
25.8
(23.2 to 29)
25.8
(23.7 to 29.1)
smoking currently  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 132 participants 265 participants
17
  12.8%
14
  10.6%
31
  11.7%
use of alcohol currently  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 132 participants 265 participants
92
  69.2%
100
  75.8%
192
  72.5%
use of neoadjuvant therapy for resection  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 132 participants 265 participants
20
  15.0%
27
  20.5%
47
  17.7%
1.Primary Outcome
Title Number of Patients Developing Postoperative Ileus
Hide Description number of patients with absence of flatus or stool passage and inability to tolerate a regular oral diet between surgery and postoperative day 4
Time Frame up to 3 weeks after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Enriched Enteral Nutrition
Hide Arm/Group Description:
standard of care
enriched enteral tube feeding
Overall Number of Participants Analyzed 133 132
Measure Type: Count of Participants
Unit of Measure: Participants
29
  21.8%
37
  28.0%
2.Secondary Outcome
Title Anastomotic Leakage
Hide Description number of patients developing anastomotic leakage
Time Frame up to 6 weeks after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Enriched Enteral Nutrition
Hide Arm/Group Description:
standard of care
enriched enteral tube feeding
Overall Number of Participants Analyzed 133 132
Measure Type: Count of Participants
Unit of Measure: Participants
11
   8.3%
12
   9.1%
3.Secondary Outcome
Title Aspiration Pneumonia
Hide Description number of patients developing aspiration pneumonia
Time Frame up to 3 week after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Enriched Enteral Nutrition
Hide Arm/Group Description:
standard of care
enriched enteral tube feeding
Overall Number of Participants Analyzed 133 132
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Gastric Motility
Hide Description Percent change in Gastric Antral Area, assessed by Ultrasound of the Gastric Antrum Following a Standardized Meal
Time Frame 3 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
not every patients was fit to have the standard meal or ultrasound, therefore less antral measurements were executed.
Arm/Group Title Standard Enriched Enteral Nutrition
Hide Arm/Group Description:
standard of care
enriched enteral tube feeding
Overall Number of Participants Analyzed 109 106
Median (Inter-Quartile Range)
Unit of Measure: percentage of decrease in antral area
-32.7
(-45.9 to -9.2)
-31.4
(-46.6 to -9.8)
5.Secondary Outcome
Title Functional Recovery
Hide Description 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
Time Frame up to 6 weeks after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Enriched Enteral Nutrition
Hide Arm/Group Description:
standard of care
enriched enteral tube feeding
Overall Number of Participants Analyzed 133 132
Median (Inter-Quartile Range)
Unit of Measure: days
5
(3 to 7)
5
(3 to 9)
6.Secondary Outcome
Title C-reactive Protein (CRP)
Hide Description the inflammatory response measured systemically (in blood): C-reactive protein (CRP)
Time Frame up to 48 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Enriched Enteral Nutrition
Hide Arm/Group Description:
standard of care
enriched enteral tube feeding
Overall Number of Participants Analyzed 113 114
Median (Inter-Quartile Range)
Unit of Measure: mg/L
150
(99 to 220)
164
(108 to 227)
7.Secondary Outcome
Title Number of Patients Needing Additional Surgical, Radiological or Endoscopic Interventions
Hide Description 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.
Time Frame up to 6 weeks after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Enriched Enteral Nutrition
Hide Arm/Group Description:
standard of care
enriched enteral tube feeding
Overall Number of Participants Analyzed 133 132
Measure Type: Count of Participants
Unit of Measure: Participants
21
  15.8%
15
  11.4%
8.Secondary Outcome
Title Number of Patients Needing ICU Admission
Hide Description number of patients needing ICU admission after surgery
Time Frame up to 6 weeks after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Enriched Enteral Nutrition
Hide Arm/Group Description:
standard of care
enriched enteral tube feeding
Overall Number of Participants Analyzed 133 132
Measure Type: Count of Participants
Unit of Measure: Participants
37
  27.8%
31
  23.5%
9.Secondary Outcome
Title Health-related Quality of Life
Hide Description 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
Time Frame 6 months after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Enriched Enteral Nutrition
Hide Arm/Group Description:
standard of care
enriched enteral tube feeding
Overall Number of Participants Analyzed 102 116
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
83
(75 to 85)
78
(67 to 83)
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Enriched Enteral Nutrition
Hide Arm/Group Description standard of care enriched enteral tube feeding
All-Cause Mortality
Standard Enriched Enteral Nutrition
Affected / at Risk (%) Affected / at Risk (%)
Total   7/133 (5.26%)   4/132 (3.03%) 
Hide Serious Adverse Events
Standard Enriched Enteral Nutrition
Affected / at Risk (%) Affected / at Risk (%)
Total   52/133 (39.10%)   55/132 (41.67%) 
Gastrointestinal disorders     
anastomotic leakage   12/133 (9.02%)  11/132 (8.33%) 
Surgical and medical procedures     
remaining serious adverse events  [1]  40/133 (30.08%)  44/132 (33.33%) 
Indicates events were collected by systematic assessment
[1]
serious adverse events according to the official definition in the study protocol, not including the patients with anastomotic leakage
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Standard Enriched Enteral Nutrition
Affected / at Risk (%) Affected / at Risk (%)
Total   22/133 (16.54%)   16/132 (12.12%) 
Surgical and medical procedures     
clavien dindo grade 1  [1]  22/133 (16.54%)  16/132 (12.12%) 
Indicates events were collected by systematic assessment
[1]
clavien dindo grade 1: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: dr Misha Luyer
Organization: Catharina Hospital
Phone: +31402399111
EMail: misha.luyer@catharinaziekenhuis.nl
Publications:
Layout table for additonal information
Responsible Party: Misha D.P. Luyer, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT02175979    
Other Study ID Numbers: NL45640.060.13
First Submitted: June 25, 2014
First Posted: June 26, 2014
Results First Submitted: May 3, 2019
Results First Posted: September 19, 2019
Last Update Posted: September 19, 2019