Pre-Surgical Immunonutrition's Effect on Colorectal Surgery

Recruiting now · Not applicable

Conditions studied: Colorectal Surgery

In brief

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.

Key facts

Study ID

NCT06883422

Run by

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

People needed

126

Starts

2023-05-25

Expected to finish

2026-12-31

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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).

Where it is running

• Aurora E Serralde Zúñiga, MD, PhD — Mexico City, Tlalpan, Mexico (enrolling)

Full record on ClinicalTrials.gov

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