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A comprehensive comparative analysis of the effectiveness of isolated enteral, isolated parenteral and mixed type of nutritional support in the early postoperative period in patients after operations performed on the malignant neoplasms of hepatico-pancreatico-duodenal zone.
A prospective, longitudinal, parallel study and retrospective analysis of the results of treatment of 91 patients with malignant tumors of the hepatico-pancreato-duodenal zone who underwent the following operations:
The first group (n=31) included patients who received enteral nutrition (EN) after surgery. The second group (n=30) included patients who received parenteral nutrition (PN) and the third group (n=30) who received mixed nutrition (MN), as a variation of the partial parenteral nutrition technique, in the early postoperative period.
Some nutritional status indicators available for determination at the Oncology Clinic were assessed - body mass index (weight measurements were carried out before surgery, on the 5th, 10th and 15th days), basal metabolic rate (calculated using the Harris-Benedict equation, based on anthropometric data of the patient (gender, age, weight and height).), laboratory parameters: blood hemoglobin, lymphocytes, total protein, serum albumin, serum transferrin, total bilirubin and direct, alanine aminotransferase (ALT), aspartate aminotransferase (AST), which are related to the traditional method for assessing nutritional status
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - enteral nutrition | Experimental | patients receiving enteral nutrition (EN) after surgery |
|
| Arm 2 - parenteral nutrition | Experimental | patients receiving parenteral nutrition (PN) |
|
| Arm 3 - mixed nutrition | Experimental | patients receiving mixed nutrition (MF) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| parenteral nutrition supplements | Dietary Supplement | parenteral nutrition |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with changes of BMI in kg/m^2 | Variables of Body mass index measured by Canadian Guidelines for Body Weight Classification in Adults | Day 0, Day 5, Day 10, Day15 |
| Basal Metabolic rate | basal metabolic rate according to the Harris-Benedict equation | Day 0, Day 5, Day 10, Day15 |
| Total protein level in Blood | Blood biochemical analysis: total protein in g/L | Day 0, Day 5, Day 10, Day15 |
| Serum albumin in g/L | Blood biochemical analysis: serum albumin in g/L | Day 0, Day 5, Day 10, Day15 |
| Serum transferrin in g/L | Blood biochemical analysis: serum transferrin in g/L | Day 0, Day 5, Day 10, Day15 |
| Total bilirubin in mmol/L | Blood biochemical analysis: total bilirubin in mmol/L | Day 0, Day 5, Day 10, Day15 |
| Direct bilirubin in mmol/L | Blood biochemical analysis: direct bilirubin in mmol/L | Day 0, Day 5, Day 10, Day15 |
| ALT in IU/L | Blood biochemical analysis: ALT in IU/L |
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Inclusion Criteria:
female and male patients in age of 20-75 with malignant tumors of the hepato-pancreato-duodenal zone who have undergone any of the following operations:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherzad Davanov, MD | Karaganda Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karaganda Medical University | Karaganda | 100008 | Kazakhstan |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 17, 2020 | Apr 29, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D010288 | Parenteral Nutrition |
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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prospective, longitudinal, parallel study
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| enteral nutrition supplements | Dietary Supplement | enteral nutrition |
|
|
| mixed nutrition supplements | Dietary Supplement | mixed nutrition |
|
|
| Day 0, Day 5, Day 10, Day15 |
| AST in IU/L | Blood biochemical analysis: AST in IU/L | Day 0, Day 5, Day 10, Day15 |