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Objective:To confirm the effect of preoperative oral nutrition therapy on patients with malnourished before liver cancer resection.
Study design:Prospective, randomized, controlled clinical study. Primary end point: incidence of all complications 30 days after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nutritional intervention | Experimental | 300 or 500 calories nutritional support before operation according to the level of malnutrition |
|
| control group | Other | Dietary education was conducted according to preoperative nutritional requirements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 300 calories or 500 calories nutrient rich in branched chain amino acids and dietary fiber | Dietary Supplement | 300 kcal rich in branched chain amino acids and water soluble dietary fiber (12g) for Mild malnutrition, or 500 kcal rich in branched chain amino acids and water soluble dietary fiber (12g) for moderate to severe malnutrition. The degree of malnutrition is determined by Patient-Generated Subjective Global Assessment (PG-SGA). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of complications at 30 days after surgery | Postoperative complications were defined by Clavien-Dindo. Grade 1: Any deviation from the normal postoperative course without the need for pharmacologic treatment or surgical, endoscopic, and radiologic interventions. Allowed therapeutic regimens are drugs as antiemetics, antipyretics, analgetics, and diuretics, and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside. Grade 2: Requiring pharmacologic treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade 3: Requiring surgical, endoscopic, or radiologic intervention 3a: Intervention not under general anesthesia 3b: Intervention under general anesthesia Grade 4:Life-threatening complication (including CNS complications) requiring IC/ICU management. 4a: Single organ dysfunction (including dialysis) 4b: Multiple organ dysfunction Grade 5: Death as a result of complications | up to 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative hospital stay | from the date of the operation to the date of discharge | up to 90 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunlei Li, Doctor | Contact | 18622370261 | lcltjmu507@163.com | |
| Kun Wang, Doctor | Contact | 23340123 | 1155 | lcltjmu507@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Kun Wang, Doctor | Tianjin Medical University cancer Instituteand Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University cancer Instituteand Hospital | Recruiting | Tianjin | China |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000596 | Amino Acids |
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
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| Dietary mission | Behavioral | Dietary education was conducted according to preoperative nutritional requirements |
|
| D008107 |
| Liver Diseases |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |