Pre-Surgical Immunonutrition's Effect on Colorectal Surgery

Официальное название

Impact of Pre-surgical Oral Immunonutrition on Plasma Levels of Branched-chain Amino Acids in Elective Colorectal Surgery Patients: a Randomized, Double-blind, Controlled, Clinical Trial

Обзор

Colorectal surgery patients face excessive catabolism, increasing inflammation and immune compromise. The administration of nutritional supplements known as immunonutrition before gastrointestinal surgery has been shown to improve clinical outcomes; however, the mechanisms underlying these benefits remain inconclusive. The objective of the study is to evaluate the effect of preoperative nutritional supplementation with an immunonutrient-enriched formula compared to an isocaloric and isoproteic formula on plasma BCAA concentration in patients undergoing elective colorectal surgery. A double-blind, randomized controlled clinical trial will be conducted. Patients will be required to drink the supplement daily for the 7 days preceding the surgical intervention. Patients in both groups will be instructed to maintain their usual food intake. During the study, there will be two patient assessments and a review of medical records to document the outcomes.

Подробное описание

Patients undergoing colorectal surgery, experience excessive and persistent catabolism, leading to skeletal muscle depletion, and increased inflammatory and immunological involvement, this results in greater malnutrition, mortality, and postoperative morbidity. Depletion of amino acids leads to an increased inflammatory response and diminished immunity. Guidelines of leading international societies in the field of clinical nutrition recommend the perioperative administration of oral formulas with immunonutrients in these patients. The administration of nutritional supplements known as immunonutrition (fortified with arginine, glutamine, branched-chain amino acids (BCAAs) and omega-3 polyunsaturated fatty acids) before gastrointestinal surgery has been shown to improve clinical outcomes, such as a reduction in post-surgical infectious, reduced risk of anastomotic leakage and fewer days of hospital stay; however, the mechanisms related to these benefits are not conclusive.

The aim of the study is to evaluate the effect of preoperative nutritional supplementation for 7 days with a formula enriched with immunonutrients compared to an isocaloric and isoproteic formula, on the plasma concentration of BCAAs in patients undergoing elective colorectal surgery. A randomized, double-blind, controlled trial will be conducted with 63 patients per group. The concentration of BCAAs will be measured prior to the 7 days of nutritional supplementation and will be repeated on the day of the surgical intervention before the procedure. The supplements for both groups will provide 500 calories, 41 g of protein, 60 g of carbohydrates, and 11 g of lipids; the supplement for the intervention group is additionally fortified with immunonutrients. Patients will be instructed to consume the supplement daily for the 7 days prior to the surgical intervention. Patients in both groups will be advised to maintain their usual food intake.

The investigators hypothesized that if an oral formula with immunonutrients is administered compared to an isocaloric and isoproteic formula without them for 7 days in the preoperative period in patients undergoing elective colorectal surgery, there will be an increase in the plasma concentration of BCAAs in the intervention group.

Вмешательства

• Пищевая добавка Preoperative oral immunonutrition formula
  Intervention arm will daily receive, for 7 days, a preoperative oral formula with immunonutrients: 500 kcal of energy, 41 g of protein, 60 g of carbohydrates, 11 g of lipids, 5.7 g of glutamine, 7 g of arginine, 3.6 g of leucine, 2.7 g of isoleucine, 3.7 g of valine, and 0.35 g of omega 3
• Пищевая добавка Preoperative oral Isocaloric and isoproteic polymeric formula
  Control arm will daily receive, for 7 days, an isocaloric and isoproteic preoperative oral formula: 500 kcal of energy, 41 g of protein, 60 g of carbohydrates, and 11 g of lipids

Первичные конечные точки

• Concentration of branched-chain amino acids [Срок оценки: The first measurement will be conducted 7 days prior to the surgical intervention (baseline measurement). The second measurement will be performed on the day of the surgical intervention, before the start of the procedure]

Вторичные конечные точки (10)

• Concentration of albumin [Срок оценки: The first measurement will be conducted 7 days prior to the surgical intervention (baseline measurement). The second measurement will be performed on the day of the surgical intervention, before the start of the procedure]
• Concentration of high-sensitivity C-reactive protein [Срок оценки: The first measurement will be conducted 7 days prior to the surgical intervention (baseline measurement). The second measurement will be performed on the day of the surgical intervention, before the start of the procedure]
• Mortality [Срок оценки: Mortality will be assessed within 30 days post-surgery]
• Length of stay [Срок оценки: Length of stay will be assessed within 30 days post-surgery]
• Hospital readmission [Срок оценки: Hospital readmission will be assessed within 30 days post-surgery]
• Anastomotic dehiscence [Срок оценки: Anastomotic dehiscence will be assessed within 30 days post-surgery]
• Surgical site infection [Срок оценки: Surgical site infection will be assessed within 30 days post-surgery]
• Fistula [Срок оценки: Fistula will be assessed within 30 days post-surgery]
• Paralytic ileus [Срок оценки: Paralytic ileus will be assessed within 30 days post-surgery]
• Postoperative intestinal obstruction [Срок оценки: Postoperative intestinal obstruction will be assessed within 30 days post-surgery]

Критерии участия

Критерии включения

• Both sexes
• Over 18 years of age
• Scheduled for elective colorectal surgery (Resection and intestinal reconnection)
• Obtaining patient consent

Критерии исключения

• Consumption of nutritional supplements during the 2 weeks prior to patient enrollment
• Consumption of additional nutritional supplements during the 7 days corresponding to the study intervention period
• Patients diagnosed with chronic kidney disease
• Patients diagnosed with hepatic cirrhosis
• Documented allergy to any of the ingredients in the formulas under evaluation (milk and/or soy).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Мексика · 1 центр

• Aurora E Serralde Zúñiga, MD, PhD — Mexico City

Публикации

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• Choudry HA, Pan M, Karinch AM, Souba WW. Branched-chain amino acid-enriched nutritional support in surgical and cancer patients. J Nutr. 2006 Jan;136(1 Suppl):314S-8S. doi: 10.1093/jn/136.1.314S. PMID 16365105
• Wischmeyer PE, Carli F, Evans DC, Guilbert S, Kozar R, Pryor A, Thiele RH, Everett S, Grocott M, Gan TJ, Shaw AD, Thacker JKM, Miller TE, Hedrick TL, McEvoy MD, Mythen MG, Bergamaschi R, Gupta R, Holubar SD, Senagore AJ, Abola RE, Bennett-Guerrero E, Kent ML, Feldman LS, Fiore JF Jr; Perioperative Quality Initiative (POQI) 2 Workgroup. American Society for Enhanced Recovery and Perioperative Quali PMID 29369092
• Finco C, Magnanini P, Sarzo G, Vecchiato M, Luongo B, Savastano S, Bortoliero M, Barison P, Merigliano S. Prospective randomized study on perioperative enteral immunonutrition in laparoscopic colorectal surgery. Surg Endosc. 2007 Jul;21(7):1175-9. doi: 10.1007/s00464-007-9238-4. Epub 2007 Mar 14. PMID 17356942
• Slim K, Badon F, Vacheron CH, Dziri C, Marquillier T. Efficacy of perioperative immunonutrition in visceral surgery: an umbrella review protocol. BMJ Open. 2021 Sep 13;11(9):e053851. doi: 10.1136/bmjopen-2021-053851. PMID 34518277
• Adiamah A, Skorepa P, Weimann A, Lobo DN. The Impact of Preoperative Immune Modulating Nutrition on Outcomes in Patients Undergoing Surgery for Gastrointestinal Cancer: A Systematic Review and Meta-analysis. Ann Surg. 2019 Aug;270(2):247-256. doi: 10.1097/SLA.0000000000003256. PMID 30817349
• Yu K, Zheng X, Wang G, Liu M, Li Y, Yu P, Yang M, Guo N, Ma X, Bu Y, Peng Y, Han C, Yu K, Wang C. Immunonutrition vs Standard Nutrition for Cancer Patients: A Systematic Review and Meta-Analysis (Part 1). JPEN J Parenter Enteral Nutr. 2020 Jul;44(5):742-767. doi: 10.1002/jpen.1736. Epub 2019 Nov 11. PMID 31709584
• Niu JW, Zhou L, Liu ZZ, Pei DP, Fan WQ, Ning W. A Systematic Review and Meta-Analysis of the Effects of Perioperative Immunonutrition in Gastrointestinal Cancer Patients. Nutr Cancer. 2021;73(2):252-261. doi: 10.1080/01635581.2020.1749291. Epub 2020 Apr 14. PMID 32285694

Идентификаторы

NCT: NCT06883422 · 4475

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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