Effect of pre-surgery nutrition on colorectal surgery outcomes
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
This study tests whether a special nutritional drink before colorectal surgery can help patients recover better and have fewer complications compared to a regular drink.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Academic / other |
| Locations | 1 site (Mexico City, Tlalpan) |
| Trial ID | NCT06883422 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of preoperative nutritional supplementation with an immunonutrient-enriched formula compared to a standard formula on plasma branched-chain amino acid (BCAA) levels in patients undergoing elective colorectal surgery. It is a double-blind, randomized controlled trial involving 126 patients who will consume the designated supplements daily for seven days before their surgery. The study aims to understand how these nutritional interventions can influence recovery and reduce complications associated with colorectal surgery.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for elective colorectal surgery who can provide consent.
Not a fit: Patients with chronic kidney disease, hepatic cirrhosis, or allergies to the study formulas will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery outcomes and reduced complications for patients undergoing colorectal surgery.
How similar studies have performed: Previous studies have shown positive outcomes with immunonutrition in surgical patients, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Both sexes * Over 18 years of age * Scheduled for elective colorectal surgery (Resection and intestinal reconnection) * Obtaining patient consent Exclusion Criteria: * 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 this trial is running
Mexico City, Tlalpan
- Aurora E Serralde Zúñiga, MD, PhD — Mexico City, Tlalpan, Mexico (Recruiting)
Study contacts
- Principal investigator: Aurora E Serralde Zúñiga, MD, PhD — Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Study coordinator: Aurora E Serralde Zúñiga, MD, PhD
- Email: aurozabeth@yahoo.com.mx
- Phone: +52 5554870900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.