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A study of the efficacy and safety of parenteral nutrition preparations supplemented with omega-3 triglycerides in patients after colorectal surgery

A study of the efficacy and safety of parenteral nutrition preparations supplemented with omega-3 triglycerides in patients after colorectal surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096807
Enrollment
Unknown
Registered
2025-02-07
Start date
2025-02-20
Completion date
Unknown
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Test group:Accept the addition of omega-3 triglyceride parenteral nutrition supplements
Control group:Accept conventional parenteral nutrition preparations

Sponsors

The First Hospital of Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients must meet all of the following inclusion criteria to be eligible for this study: 1. Age >= 18 years old and <= 80 years old, gender is not limited; 2. Pathologically diagnosed with colorectal cancer without distant metastasis, and elective radical surgery; 3. Operational nutrition screening, which is expected to require parenteral nutrition support at least 5 days after surgery; 4. American Society of Anesthesiologists (ASA) grade I-III; 5. The patient or his/her family members sign the informed consent form.

Exclusion criteria

Exclusion criteria: Patients cannot be enrolled if they meet any of the following criteria: 1. Allergies to omega-3 triglycerides or other pharmaceutical ingredients (such as egg or soy protein, peanut protein, or other ingredients in the prescription); 2. Severe malnutrition (such as body mass index < 18.5kg/m2 or serum albumin <30 g/L) before surgery; 3. Those who received enteral or parenteral nutrition therapy within 7 days before surgery; 4. Combined with severe dysfunction of important organs such as heart, liver, and kidney; 5. Immune system disease or is receiving immunosuppressive therapy, or has undergone splenectomy; 6. Pregnant or lactating women; 7. Patients with mental disorders or unable to cooperate with treatment and follow-up; 8. Patients with general intravenous infusion contraindications, electrolyte and fluid balance disorders, and metabolic disorders (including protein metabolism disorders, lipid metabolism disorders, and hyperglycemia that does not respond to a 6 unit insulin/hour dose) during the screening period; 9. Serious complications (such as hemorrhagic shock, acute single or multi-organ dysfunction, etc.) during the operation; 10. Other factors that the investigator considers unsuitable to participate in this experiment.

Design outcomes

Primary

MeasureTime frame
Nutritional indicators: serum albumin, prealbumin, transferrin;;Inflammation-related indicators: C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-a (TNF-a), interleukin-1ß (IL-1ß), interleukin-8 (IL-8);;

Secondary

MeasureTime frame
Nutritional indicators: retinol binding protein, nitrogen balance, body mass index, triceps skinfold thickness, and mid upper arm muscle circumference;Immune function indicators: T lymphocyte subsets, immunoglobulin levels, blood routine;Clinical indicators: postoperative hospital stay, incidence of postoperative complications (bleeding, infection, incidence of intestinal fistula);Recovery indicators: recovery time of bowel sounds, first bowel movement time;

Countries

China

Contacts

Public ContactZhu Xiaoliang

The First Hospital of Lanzhou University

zhuxiaoliang1981@163.com+86 139 1934 5134

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026