Effects of Preoperative Parenteral Nutrition With Omega-3 Fish Oil Lipid Emulsion on Postoperative Outcomes in Patients Undergoing Major Abdominal Surgery

NCT07878468 · tracked via the Priya Life Science China tracker

Sponsor

Second Affiliated Hospital of Nanchang University

Phase

Phase 4

Started

2026-10

Last updated

2026-10-16

Condition(s) studied

Parenteral NutritionNutritional StatusMajor Abdominal Surgery

Investigational drug(s) / intervention(s)

ω-3 fish oil lipid emulsionConventional lipid without ω-3 fish oil

ω-3 fish oil lipid emulsion: In the ω-3 group, receive preoperative parenteral nutrition containing ω-3 fish oil lipid emulsion.

Conventional lipid without ω-3 fish oil: Receiving parenteral nutrition without fish oil fat emulsion with equal nitrogen and heat content

Study summary

The goal of this study is to explore if preoperative ω-3 fish oil lipid emulsion parenteral nutrition (PN) can improve postoperative outcomes in patients undergoing major abdominal surgery. The main questions it aims to answer are:

* Does preoperative PN containing ω-3 fish oil lipid emulsion improve postoperative nutritional status (prealbumin, albumin) in patients undergoing major abdominal surgery?
* Does preoperative PN containing ω-3 fish oil lipid emulsion affect other postoperative clinical outcomes (length of hospital stay, inflammatory status, postoperative complication rates, BMI changes, liver function changes, time to first flatus and defecation) in these patients? Researchers will compare the ω-3 fish oil lipid emulsion PN group (preoperative ω-3 PN) to the control group (preoperative normal diet) to see if there are differences in postoperative nutritional status, safety, and other clinical outcomes.

Participants will:

* In the intervention group, receive preoperative parenteral nutrition containing ω-3 fish oil lipid emulsion.
* In the control group, maintain a normal preoperative diet.
* Undergo blood tests and clinical assessments at baseline (before PN use) and on postoperative days 1, 3, and 7 (or at discharge, whichever comes first).

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. 18 - 80 years old; 2. NRS2002 score ≥ 3 points; 3. Diagnosed as malnourished or at high risk of malnutrition according to the GLIM standard; 4. Patients undergoing elective major abdominal surgery with an estimated operation time of ≤ 4 hours; 5. Voluntary participants in this clinical study, with patients or their families signing the informed consent form. Exclusion Criteria: 1. Patients with severe hyperlipidemia (such as hypertriglyceridemia), severe coagulation disorders or acute thrombo/thrombotic diseases (including fat embolism), intrahepatic cholestasis, liver failure, renal failure that cannot undergo hemofiltration/dialysis, acute myocardial infarction or stroke; 2. Patients with moderate/severe diseases (sepsis, mechanical intestinal obstruction); 3. Have the following contraindications for intravenous infusion: hemodynamic instability (such as collapse or shock), metabolic disorders (severe trauma, severe sepsis, acidosis), insufficient cellular oxygen supply, acute pulmonary edema, compensatory heart failure, or electrolyte imbalance (water intoxication, hypotonic dehydration, hypokalemia); 4. Pregnant or lactating; 5. Have immune system diseases or are undergoing immunomodulatory therapy or have undergone splenectomy; 6. Use glucocorticoid anti-inflammatory drugs, thyroid drugs; 7. Allergic to ω-3 fat emulsions or allergic to other drug components used in the study (such as eggs, fish, soy protein, peanut protein or other components in the prescription); 8. Have mental disorders or are unable to cooperate with treatment and follow-up; 9. Participate in other clinical trials; 10. The investigator deems it inappropriate for the patient to participate in this study for other reasons.

Primary outcome measure(s)

Serum albumin and prealbumin levels — Preoperative Day 1, and postoperative Days 1, 3, and 7
Levels of serum albumin and prealbumin will be measured at baseline (preoperative Day 1) and postoperatively on Days 1, 3, and 7. If discharged before Day 7, the final measurement will be taken on the day of discharge.
Length of hospital stay (days) — From surgery to hospital discharge (up to 30 days)
Length of hospital stay will be calculated as the number of days from surgery to discharge. If a patient is still hospitalized at the end of the study period, the outcome will be censored at 30 days.

Trial sites (7)

Facility	City	Region
The People's Hospital of Dexing	Dexing	Jiangxi
The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
The First Hospital of Nanchang	Nanchang	Jiangxi
Jiangxi Cancer Hospital	Nanchang	Jiangxi
The People's Hospital of Wanzai County	Wanzai	Jiangxi
Yichun People's Hospital	Yichun	Jiangxi
Ganzhou People's Hospital	Ganzhou	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07878468 on ClinicalTrials.gov ↗ ← All trials in China