Effect of Preoperative Immunonutrition in Upper Digestive Tract
Түлхүүр үгс
Хураангуй
Тодорхойлолт
Background:
Perioperative nutritional status is a key factor in the evolution, as well as, postoperative morbidity and mortality of cancer patients. Particularly, digestive neoplasms have a high risk of malnutrition and this is related to a higher rate of surgery complications and mortality in the postoperative period. The immunonutrition seems to modulate the immune system and the inflammatory response in patients operated on for digestive neoplasia. However, the results to date are controversial.
Aim:
To compare the effect of an immunomodulatory oral nutritional supplement (enriched in arginine, nucleotides, omega 3 fatty acids, olive oil polyphenols, L-carnitine, and antioxidants) against an equivalent in protein-energy without immunonutrients, administrated in the preoperative period, in the surgical evolution of the cancer patient with neoplasia of the upper digestive tract.
Methods:
It is a randomized, double-blind, multicenter clinical trial. 178 patients with neoplasms of the esophagus, stomach or pancreas, with indication of surgical treatment, will be included. The patients will be randomized into two groups (intervention group and control group) and both will receive 2 daily bricks of the assigned formula (with or without immunonutrients, respectively) 5 days prior to surgery. The main variables of the study are: appearance of infectious or noninfectious complications in the postoperative period, length of hospital stay, and mortality. These variables will be compared by group (immunonutrition vs. non immunonutrition).
Огноо
| Сүүлд баталгаажуулсан: | 07/31/2019 |
| Эхлээд оруулсан: | 07/15/2019 |
| Тооцоолсон элсэлтийг оруулсан: | 07/17/2019 |
| Эхлээд нийтэлсэн: | 07/18/2019 |
| Сүүлийн шинэчлэлтийг оруулсан: | 08/18/2019 |
| Сүүлийн шинэчлэлтийг нийтэлсэн: | 08/19/2019 |
| Сургалтын бодит эхлэх огноо: | 08/09/2019 |
| Тооцоолсон анхан шатны ажил дуусах огноо: | 08/09/2021 |
| Судалгааны ажлыг дуусгах өдөр: | 12/30/2021 |
Нөхцөл байдал эсвэл өвчин
Хөндлөнгийн оролцоо / эмчилгээ
Dietary Supplement: Immunonutrition
Dietary Supplement: Standard
Үе шат
Arm Groups
| Гар | Хөндлөнгийн оролцоо / эмчилгээ |
|---|---|
| Experimental: Immunonutrition Oral nutritional supplement: hypercaloric and hyperproteic with immunonutrients: Arginine, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine | Dietary Supplement: Immunonutrition It is a hypercaloric and hyperproteic dietary supplement formulated with immunonutrients: Arginin, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine |
| Placebo Comparator: Standard Oral nutritional supplement: hypercaloric and hyperproteic without immunonutrients | Dietary Supplement: Standard It is a hypercaloric and hyperproteic dietary supplement formulated without immunonutrients |
Эрхийн шалгуур
| Суралцах боломжтой нас | 18 Years Хэнд 18 Years |
| Суралцах боломжтой хүйс | All |
| Эрүүл сайн дурын ажилтнуудыг хүлээн авдаг | Тийм ээ |
| Шалгуур үзүүлэлтүүд | Inclusion Criteria: - Diagnosis of cancer of esophagus, stomach and / or pancreas, at any stage, proposed for surgery - Signing informed consent Exclusion Criteria: - Pregnant or breastfeeding - Advanced renal insufficiency prior to dialysis (GFR <25 ml / min) - Allergy or intolerance to any of the components of the dietary supplement (including fish allergy) - Patients with contraindications for enteral nutrition |
Үр дүн
Анхан шатны үр дүнгийн арга хэмжээ
1. Infectious complications [Up to 30 days post-operative]
2. Surgical fistulas [Up to 30 days post-operative]
Хоёрдогч үр дүнгийн арга хэмжээ
1. Mortality [Up to 30 days post-operative]
2. Length of hospital stay [Up to 30 days post-operative]
3. Weight loss [10 days Pre-operative]
