## Protocol Section
### Identification Module
**NCT ID:** NCT02175979

**Acronym:** SANICSII

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

**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

#### Organization Study ID Info
**ID:** NL45640.060.13
#### Organization
**Class:** OTHER
**Full Name:** Catharina Ziekenhuis Eindhoven
### Status Module
#### Completion Date
**Date:** 2017-12-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-09-19

**Type:** ACTUAL

**Last Update Submit Date:** 2019-08-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-03-20

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-09-19

**Type:** ACTUAL

**Results First Submit Date:** 2019-05-03

**Results First Submit QC Date:** 2019-08-14

#### Start Date
**Date:** 2014-08

**Status Verified Date:** 2019-08

#### Study First Post Date
**Date:** 2014-06-26
**Type:** ESTIMATED
**Study First Submit Date:** 2014-06-25
**Study First Submit QC Date:** 2014-06-25
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Danone Research

**Class:** OTHER

**Name:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

**Class:** OTHER

**Name:** ZonMw: The Netherlands Organisation for Health Research and Development

**Class:** OTHER

**Name:** Fonds NutsOhra

#### Lead Sponsor

**Class:** OTHER

**Name:** Misha D.P. Luyer

#### Responsible Party

**Investigator Affiliation:** Catharina Ziekenhuis Eindhoven

**Investigator Full Name:** Misha D.P. Luyer

**Investigator Title:** dr. M.D.P. Luyer

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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).

**Detailed Description:** Postoperative ileus (POI) and anastomotic leakage (AL) are important clinical determinants of short-term morbidity and mortality following colorectal surgery. Importantly, AL is also a risk factor for local recurrence of colorectal cancer and has a significant impact on disease-free and overall survival. It is therefore believed that improving postoperative outcome following colorectal surgery will also improve long-term oncological outcomes regarding overall survival and tumour recurrence. POI is a common complication after colorectal surgery that causes discomfort for the patient but also leads to a prolonged hospital length of stay and increasing health care costs. For POI it is believed that formation of an inflammatory infiltrate in the muscular layers of the intestine following bowel manipulation during surgery leads to a decreased gastrointestinal motility. In recent years the investigators have demonstrated in experimental models that administration of enteral nutrition modulates the inflammatory response via the autonomic nervous system by release of cholecystokinin (CCK). Composition of the enteral nutrition and timing of administration are both essential for the magnitude of effect. For the most optimal effect, nutrition is given with a higher fraction of lipids and protein and is administered just before, during and directly after the inciting event. In this way, the inflammatory response is optimally dampened via release of CCK. In an experimental study has been shown that such a lipid-enriched enteral nutrition reduces systemic inflammation and postoperative ileus in a CCK-dependent manner when given just before and directly after bowel manipulation. Next, the investigators performed a study in healthy volunteers in which the effect of continuous low volume enteral nutrition was investigated on inflammatory parameters in a human endotoxemia model. In this study was shown that lipid enriched nutrition reduced the inflammatory response upon endotoxemia in man. Also in a clinical setting the investigators have shown that enteral nutrition reduces inflammation and postoperative ileus. In a randomized controlled trial the investigators have shown that enteral nutrition early after colorectal surgery reduced POI. Furthermore, in a model of sham-feeding using chewing gum was shown that inflammation and postoperative ileus were reduced following colorectal surgery. Interestingly, both clinical studies with sham feeding and early enteral nutrition revealed a yet unaccountable effect on anastomotic leakage. Evidence on the relation between POI and anastomotic leakage is scarce but has great impact. It seems that an early intervention with enteral nutrition shortly before, during and early after colorectal surgery may reduce inflammation and reduce important determinants in postoperative morbidity as POI and anastomotic leakage.

All patients will receive a self-migrating nasojejunal tube one day before surgery. The position of the nasojejunal tube is verified by means of an X-ray at the night before surgery. Preoperatively, patients receive standard of care with a fast for solid (oral) food of 6 hours and a (oral) fluid fast for 2 hours before administration. Three hours before surgery the pump is started to administer nutrition in standardized amounts. Enriched enteral nutrition (produced by Danone research) is administered via a programmed Flocare enteral feeding pump. The pump is connected to the opaque branched system that is connected both to the nasojejunal tube and to a sealed container. Patients are either allocated to the experimental group, in which the blinded branched system leads the enteral nutrition via the nasojejunal tube to the patient. Via this route, the patients in the experimental group will receive the enteral nutrition just before, during and directly after surgery. In patients allocated to the control group, the blinded branched system leads the enteral nutrition to the container. Consequently, when the feeding pump starts just before surgery, patients in the control group do not receive the nutrition. In both groups, the pump with enteral nutrition is stopped 6 hours after surgery and normal intake is resumed.

Based on previous results a power calculation is performed. For POI a sample size of at least 91 patients per group is needed based on a power of 0.8 and an alpha of 0.05. For AL a reduction of AL of at least 75% was observed in the previous clinical studies. Using a power of 0.8 and a drop-out percentage of 5% a total of 140 patients are needed per group. Since perioperative nutrition is a new concept, a safety analysis is performed after inclusion of 40 patients in which feasibility and safety of preoperative nutrition are assessed. The effect size is determined based on previous studies and is substantial. Considering the size of the effect, an interim-analysis will be performed after inclusion of 140 patients.

All analyses will be done according to the intention-to-treat approach in which all randomized patients are included, regardless of adherence to the study protocol. Occurrences of the primary and secondary endpoints are compared between the treatment groups. Results are presented as risk ratios with corresponding 95% confidence intervals. A two-tailed P \< 0.05 is considered statistically significant. To compare the groups, the data will be tested for normal distribution and an unpaired T-test will be performed when appropriate, otherwise the Mann-Whitney U or Chi-square tests. SPSS (Statistical Package for the Social Sciences version 20) will be used to analyze the data.

The investigators respect the Dutch Scientific Code of conduct with regard to collection and storage of our data. The investigators hereby mind the criteria of retrievability, accessibility and interchangeability of the data. The investigators will obtain written informed consent from all patients, in which is stated that their records will be used and saved for research purposes for a minimum of 15 years. Anonymity and confidentiality of data will be guaranteed compliant with CBP (Commission Protection of Personal Data) guidelines. Thus, all variables will be registered anonymously, but via a secured code, personally identifiable information can be retrieved. The investigators verified completeness of patient Data Management Strategy via the Data Archiving and Networked Services checklist. Rough data will be stored in a digital archive, with appended description, to interpret the data.

### Conditions Module

**Conditions:**

- Postoperative Ileus

- Anastomotic Leak

**Keywords:**

- postoperative ileus

- anastomotic leak

- colorectal surgery

- inflammation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 280

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** standard of care

**Intervention Names:**

- Dietary Supplement: standard

**Label:** standard

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** enriched enteral tube feeding 1.5ml/ minute perioperative

**Intervention Names:**

- Dietary Supplement: enriched enteral nutrition

**Label:** enriched enteral nutrition

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- enriched enteral nutrition

**Description:** enriched enteral tube feeding perioperative

**Name:** enriched enteral nutrition

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- standard

**Description:** standard of care

**Name:** standard

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**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

**Measure:** Number of Patients Developing Postoperative Ileus

**Time Frame:** up to 3 weeks after surgery

#### Secondary Outcomes

**Description:** number of patients developing anastomotic leakage

**Measure:** Anastomotic Leakage

**Time Frame:** up to 6 weeks after surgery

**Description:** number of patients developing aspiration pneumonia

**Measure:** Aspiration Pneumonia

**Time Frame:** up to 3 week after surgery

**Description:** Percent change in Gastric Antral Area, assessed by Ultrasound of the Gastric Antrum Following a Standardized Meal

**Measure:** Gastric Motility

**Time Frame:** 3 days after surgery

**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

**Measure:** Functional Recovery

**Time Frame:** up to 6 weeks after surgery

**Description:** the inflammatory response measured systemically (in blood): C-reactive protein (CRP)

**Measure:** C-reactive Protein (CRP)

**Time Frame:** up to 48 hours after surgery

**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.

**Measure:** Number of Patients Needing Additional Surgical, Radiological or Endoscopic Interventions

**Time Frame:** up to 6 weeks after surgery

**Description:** number of patients needing ICU admission after surgery

**Measure:** Number of Patients Needing ICU Admission

**Time Frame:** up to 6 weeks after surgery

**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

**Measure:** Health-related Quality of Life

**Time Frame:** 6 months after surgery

### Eligibility Module

**Eligibility 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Randers

**Country:** Denmark

**Facility:** Regionshospitalet Randers

**Zip:** 8930

**Location 2:**

**City:** Viborg

**Country:** Denmark

**Facility:** Regionshospitalet Viborg

**Zip:** 8800

**Location 3:**

**City:** Eindhoven

**Country:** Netherlands

**Facility:** Catharina Ziekenhuis

**State:** Noord-Brabant

**Zip:** 5623EJ

**Location 4:**

**City:** Veldhoven

**Country:** Netherlands

**Facility:** Maxima Medical Center

**State:** Noord-Brabant

**Zip:** 5504DB

**Location 5:**

**City:** Helmond

**Country:** Netherlands

**Facility:** Elkerliek Ziekenhuis

**Zip:** 5707HA

#### Overall Officials

**Official 1:**

**Affiliation:** Catharina Ziekenhuis Eindhoven

**Name:** Misha DP Luyer, MD PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

## Document Section

### Large Document Module

#### Large Docs

- Date: 2015-03-04

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 237197

- Type Abbrev: Prot_SAP

- Upload Date: 2019-08-14T10:41

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

- ID: M25585

- Name: Ileus

- Relevance: LOW

- As Found: Unknown

- ID: M28891

- Name: Anastomotic Leak

- Relevance: HIGH

- As Found: Anastomotic Leak

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000057868

- Term: Anastomotic Leak

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Standard

**Deaths Num Affected:** 7

**Deaths Num At Risk:** 133

**Description:** standard of care

**ID:** EG000

**Other Num Affected:** 22

**Other Num at Risk:** 133

**Serious Number Affected:** 52

**Serious Number At Risk:** 133

**Title:** Standard

**Group ID:** EG001

**Title:** Enriched Enteral Nutrition

**Deaths Num Affected:** 4

**Deaths Num At Risk:** 132

**Description:** enriched enteral tube feeding

**ID:** EG001

**Other Num Affected:** 16

**Other Num at Risk:** 132

**Serious Number Affected:** 55

**Serious Number At Risk:** 132

**Title:** Enriched Enteral Nutrition

**Frequency Threshold:** 5

#### Other Events

**Term:** clavien dindo grade 1

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** clavien dindo grade 1: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** 

#### Serious Events

**Term:** anastomotic leakage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 12

**Num At Risk:** 133

**Group ID:** EG001

**Num Affected:** 11

**Num At Risk:** 132

**Term:** remaining serious adverse events

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** serious adverse events according to the official definition in the study protocol, not including the patients with anastomotic leakage

**Organ System:** Surgical and medical procedures

##### Stats

**Group ID:** EG000

**Num Affected:** 40

**Num At Risk:** 133

**Group ID:** EG001

**Num Affected:** 44

**Num At Risk:** 132

**Time Frame:** 3 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 133

**Group ID:** BG001

**Value:** 132

**Group ID:** BG002

**Value:** 265

**Units:** Participants

### Group

**ID:** BG000

**Title:** Standard

**Description:** standard of care

standard: standard of care

### Group

**ID:** BG001

**Title:** Enriched Enteral Nutrition

**Description:** enriched enteral tube feeding 1.5ml/ minute perioperative

enriched enteral nutrition: enriched enteral tube feeding perioperative

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 63

**Upper Limit:** 74

**Value:** 68

#### Measurement

**Group ID:** BG001

**Lower Limit:** 62

**Upper Limit:** 75

**Value:** 69

#### Measurement

**Group ID:** BG002

**Lower Limit:** 63

**Upper Limit:** 68

**Value:** 68

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 133

**Group ID:** BG001

**Value:** 132

**Group ID:** BG002

**Value:** 265

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 55

#### Measurement

**Group ID:** BG001

**Value:** 52

#### Measurement

**Group ID:** BG002

**Value:** 107

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 78

#### Measurement

**Group ID:** BG001

**Value:** 80

#### Measurement

**Group ID:** BG002

**Value:** 158

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 133

**Group ID:** BG001

**Value:** 132

**Group ID:** BG002

**Value:** 265

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 0

**Group ID:** BG001

**Value:** 0

**Group ID:** BG002

**Value:** 0

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 101

#### Measurement

**Group ID:** BG001

**Value:** 103

#### Measurement

**Group ID:** BG002

**Value:** 204

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 133

**Group ID:** BG001

**Value:** 132

**Group ID:** BG002

**Value:** 265

**Class Title:** Netherlands

#### Measurement

**Group ID:** BG000

**Value:** 32

#### Measurement

**Group ID:** BG001

**Value:** 29

#### Measurement

**Group ID:** BG002

**Value:** 61

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 133

**Group ID:** BG001

**Value:** 132

**Group ID:** BG002

**Value:** 265

**Class Title:** Denmark

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 24

**Upper Limit:** 29.3

**Value:** 26

#### Measurement

**Group ID:** BG001

**Lower Limit:** 23.2

**Upper Limit:** 29

**Value:** 25.8

#### Measurement

**Group ID:** BG002

**Lower Limit:** 23.7

**Upper Limit:** 29.1

**Value:** 25.8

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 133

**Group ID:** BG001

**Value:** 132

**Group ID:** BG002

**Value:** 265

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 17

#### Measurement

**Group ID:** BG001

**Value:** 14

#### Measurement

**Group ID:** BG002

**Value:** 31

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 133

**Group ID:** BG001

**Value:** 132

**Group ID:** BG002

**Value:** 265

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 92

#### Measurement

**Group ID:** BG001

**Value:** 100

#### Measurement

**Group ID:** BG002

**Value:** 192

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 133

**Group ID:** BG001

**Value:** 132

**Group ID:** BG002

**Value:** 265

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 20

#### Measurement

**Group ID:** BG001

**Value:** 27

#### Measurement

**Group ID:** BG002

**Value:** 47

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 133

**Group ID:** BG001

**Value:** 132

**Group ID:** BG002

**Value:** 265

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Race and Ethnicity were not collected from any participant.
**Title:** Race and Ethnicity Not Collected
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 5
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** BMI
**Unit of Measure:** kg/m^2
### Measure 6
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** smoking currently
**Unit of Measure:** Participants
### Measure 7
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** use of alcohol currently
**Unit of Measure:** Participants
### Measure 8
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** use of neoadjuvant therapy for resection
**Unit of Measure:** Participants
**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.
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** misha.luyer@catharinaziekenhuis.nl
**Organization:** Catharina Hospital
**Phone:** +31402399111
**Title:** dr Misha Luyer
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 29
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 37
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -45.9
- **Spread:** 
- **Upper Limit:** -9.2
- **Value:** -32.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -46.6
- **Spread:** 
- **Upper Limit:** -9.8
- **Value:** -31.4
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3
- **Spread:** 
- **Upper Limit:** 7
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3
- **Spread:** 
- **Upper Limit:** 9
- **Value:** 5
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 99
- **Spread:** 
- **Upper Limit:** 220
- **Value:** 150
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 108
- **Spread:** 
- **Upper Limit:** 227
- **Value:** 164
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 37
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 31
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 75
- **Spread:** 
- **Upper Limit:** 85
- **Value:** 83
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 67
- **Spread:** 
- **Upper Limit:** 83
- **Value:** 78
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**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
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** up to 3 weeks after surgery
**Title:** Number of Patients Developing Postoperative Ileus
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** standard of care
**ID:** OG000
**Title:** Standard
##### Group
**Description:** enriched enteral tube feeding
**ID:** OG001
**Title:** Enriched Enteral Nutrition
#### Outcome Measure 2
**Description:** number of patients developing anastomotic leakage
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** up to 6 weeks after surgery
**Title:** Anastomotic Leakage
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** standard of care
**ID:** OG000
**Title:** Standard
##### Group
**Description:** enriched enteral tube feeding
**ID:** OG001
**Title:** Enriched Enteral Nutrition
#### Outcome Measure 3
**Description:** number of patients developing aspiration pneumonia
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** up to 3 week after surgery
**Title:** Aspiration Pneumonia
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** standard of care
**ID:** OG000
**Title:** Standard
##### Group
**Description:** enriched enteral tube feeding
**ID:** OG001
**Title:** Enriched Enteral Nutrition
#### Outcome Measure 4
**Description:** Percent change in Gastric Antral Area, assessed by Ultrasound of the Gastric Antrum Following a Standardized Meal
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** not every patients was fit to have the standard meal or ultrasound, therefore less antral measurements were executed.
**Reporting Status:** POSTED
**Time Frame:** 3 days after surgery
**Title:** Gastric Motility
**Type:** SECONDARY
**Unit of Measure:** percentage of decrease in antral area
##### Group
**Description:** standard of care
**ID:** OG000
**Title:** Standard
##### Group
**Description:** enriched enteral tube feeding
**ID:** OG001
**Title:** Enriched Enteral Nutrition
#### Outcome Measure 5
**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
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** up to 6 weeks after surgery
**Title:** Functional Recovery
**Type:** SECONDARY
**Unit of Measure:** days
##### Group
**Description:** standard of care
**ID:** OG000
**Title:** Standard
##### Group
**Description:** enriched enteral tube feeding
**ID:** OG001
**Title:** Enriched Enteral Nutrition
#### Outcome Measure 6
**Description:** the inflammatory response measured systemically (in blood): C-reactive protein (CRP)
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** up to 48 hours after surgery
**Title:** C-reactive Protein (CRP)
**Type:** SECONDARY
**Unit of Measure:** mg/L
##### Group
**Description:** standard of care
**ID:** OG000
**Title:** Standard
##### Group
**Description:** enriched enteral tube feeding
**ID:** OG001
**Title:** Enriched Enteral Nutrition
#### Outcome Measure 7
**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.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** up to 6 weeks after surgery
**Title:** Number of Patients Needing Additional Surgical, Radiological or Endoscopic Interventions
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** standard of care
**ID:** OG000
**Title:** Standard
##### Group
**Description:** enriched enteral tube feeding
**ID:** OG001
**Title:** Enriched Enteral Nutrition
#### Outcome Measure 8
**Description:** number of patients needing ICU admission after surgery
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** up to 6 weeks after surgery
**Title:** Number of Patients Needing ICU Admission
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** standard of care
**ID:** OG000
**Title:** Standard
##### Group
**Description:** enriched enteral tube feeding
**ID:** OG001
**Title:** Enriched Enteral Nutrition
#### Outcome Measure 9
**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
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** 6 months after surgery
**Title:** Health-related Quality of Life
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** standard of care
**ID:** OG000
**Title:** Standard
##### Group
**Description:** enriched enteral tube feeding
**ID:** OG001
**Title:** Enriched Enteral Nutrition
### Participant Flow Module
#### Group
**Description:** standard of care
**ID:** FG000
**Title:** Standard
#### Group
**Description:** enriched enteral tube feeding 1.5ml/ minute perioperative
**ID:** FG001
**Title:** Enriched Enteral Nutrition
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 140
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 140
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 133
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 132
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 8
**Has Results:** True