Nutrition Insights Day Asia

Study Overview
=================
Brief Summary
-----------------
This is an observational, cross-sectional study to be conducted on the Nutrition Insights Day (NID), with retrospective review of patient medical charts. No prospective follow-up period is considered. This study aims to obtain a contemporary overview of the nutritional status, the use of EN and/or PN and the provision of calories and proteins in patients after major elective gastrointestinal surgery with existing malnutrition or at risk of hospital malnutrition in selected Asian countries.

Official Title
-----------------
Nutrition Insights Day Asia to Assess Hospital Malnutrition and the Routine Use of Enteral and Parenteral Nutrition in Patients Following Major Gastrointestinal Surgery

Conditions
-----------------
Nutritional Status, Malnutrition, Caloric Deficit, Protein Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients after elective major abdominal gastrointestinal surgery [i.e. elective major GI resections, partial or total, especially for cancer, including: esophagectomy, gastrectomy, enterectomy (small bowel resection), colectomy, hepatectomy, pancreatectomy, resections for gall bladder or bile duct cancer (cholangiocarcinoma)] with pre-existing malnutrition or who are at significant risk for malnutrition or nutrition-related complications*, with indications for nutritional support Hospitalization on SICU or major surgical ward on the NID Use of EN (nutritional intake provided via tube feeding) and/or PN for at least one day before the NID If patient received oral nutrition (ON) or oral nutrition supplements (ONS) during the observational phase from day -5 to day -2, complete and reliable data of daily caloric and protein intake is available Latest surgical intervention ≤ 10 days before NID Exclusion Criteria: Patients with burn injuries Patients requiring postsurgical mechanical ventilation and sedation on the NID Patients receiving ON and/or ONS at any quantity on the day before the NID Patients requiring emergency procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical patients<br>Adult patients after elective major abdominal gastrointestinal surgery with pre-existing malnutrition or who are at significant risk for malnutrition or nutrition-related complications, with indications for nutritional support | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of surgical patients with a caloric / protein deficit receiving EN and/or PN on the day before the NID in selected Asian countries. | Caloric / protein deficit, i.e., difference between energy / protein target per day and actually administered energy/protein | On the day before the Nutrition Insights Day (day -1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute and relative caloric and protein balance | Absolute and relative caloric and protein balance | On the day before the Nutrition Insights Day (day -1) | 
| Distribution within subcategories of caloric / protein balance | Distribution within subcategories of caloric / protein balance | On the day before the Nutrition Insights Day (day -1) | 
| Cumulative (absolute/ relative) caloric and protein balance | Cumulative (absolute/ relative) caloric and protein balance | On the day before the Nutrition Insights Day (day -1) | 
| Categorical, absolute and relative caloric balance based on standardized target intake (sensitivity analysis) | Categorical, absolute and relative caloric balance based on standardized | On the day before the Nutrition Insights Day (day -1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICU, nutritional status, malnutrition, energy intake, protein intake, surgical ward, hospital, enteral nutrition, parenteral nutrition, nutrition