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Not yet recruitingNCT07878468Updated Oct 16, 2026

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

A Phase 4 interventional study of ω-3 fish oil lipid emulsion and Conventional lipid without ω-3 fish oil in Parenteral Nutrition, Nutritional Status and Major Abdominal Surgery, sponsored by Second Affiliated Hospital of Nanchang University. Not yet recruiting at 7 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Second Affiliated Hospital of Nanchang University · Phase 4, Interventional, and Treatment

Updated Oct 16, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
158
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

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).
02

Conditions studied

  • Parenteral Nutrition
  • Nutritional Status
  • Major Abdominal Surgery

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03

In context

Hyperphagia

99 studies on the registry are indexed under Hyperphagia; 26 are open to participants now.

This study's planned enrollment of 158 is above the median of 50 across 85 interventional studies indexed under Hyperphagia.

Browse Hyperphagia studies →

Lead sponsor

Second Affiliated Hospital of Nanchang University is the lead sponsor of 81 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
158 participants (estimated)

Study arms

  • Experimental
    ω-3 group

    Two days before the scheduled surgery, while maintaining a normal diet, an intravenous infusion of parenteral nutrition solution prepared from ω-3 fish oil and medium/long chain fat emulsion was administered daily.

    Drug: ω-3 fish oil lipid emulsion

  • Active comparator
    Conventional lipid group

    Receiving parenteral nutrition without fish oil fat emulsion with equal nitrogen and heat content

    Drug: Conventional lipid without ω-3 fish oil

Interventions

  • Drugω-3 fish oil lipid emulsion

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

  • DrugConventional lipid without ω-3 fish oil

    Receiving parenteral nutrition without fish oil fat emulsion with equal nitrogen and heat content

06

What researchers measure

Primary outcomes

  1. Serum albumin and prealbumin levels

    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.

    Time frame: Preoperative Day 1, and postoperative Days 1, 3, and 7

  2. Length of hospital stay (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.

    Time frame: From surgery to hospital discharge (up to 30 days)

Secondary outcomes

  1. White blood cell count, lymphocyte count, and C-reactive protein (CRP) levels

    Levels of white blood cells (WBC), lymphocytes, and C-reactive protein (CRP) will be measured from blood samples at baseline (preoperative Day 1) and postoperatively on Days 1, 3, and 7.

    Time frame: Baseline (Day -1), and postoperative Days 1, 3, and 7

  2. Incidence of postoperative complications (hypoproteinemia, anastomotic leakage, ileus, postoperative hemorrhage, renal failure, and thromboembolic events)

    Postoperative complications will be monitored and recorded from the end of surgery until hospital discharge, with a maximum follow-up of 30 days after surgery. The complications assessed include hypoproteinemia, anastomotic leakage, ileus, postoperative hemorrhage, renal failure, and thromboembolic events.

    Time frame: From surgery to hospital discharge (up to 30 days post-surgery)

  3. Total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) levels

    Serum levels of total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) will be measured from blood samples at baseline (preoperative Day 1) and postoperatively on Days 1, 3, and 7.

    Time frame: Baseline (Day -1), and postoperative Days 1, 3, and 7

  4. Time to first flatus and defecation

    Time to first flatus and time to first defecation will be defined as the interval (in hours or days) from the end of surgery to the first postoperative passage of flatus or defecation, respectively. Patients will be followed daily during hospitalization.

    Time frame: From the end of surgery up to postoperative Day 7

07

Study locations

7 sites
  • The People's Hospital of Dexing
    Dexing, Jiangxi 334200, China
  • The Second Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi 330006, China
  • The First Hospital of Nanchang
    Nanchang, Jiangxi 330008, China
  • Jiangxi Cancer Hospital
    Nanchang, Jiangxi 330029, China
  • The People's Hospital of Wanzai County
    Wanzai, Jiangxi 336100, China
  • Yichun People's Hospital
    Yichun, Jiangxi 336000, China
  • Ganzhou People's Hospital
    Ganzhou, 341000, China
08

References and documents

Individual participant data

Plan to share: Yes — After the article is published, de-identified data can be obtained from corresponding author upon reasonable request.

Supporting information: Study protocol, Clinical study report

Time frame: After the article is published

Access criteria: After the article is published, all can access the IPD and supporting information from corresponding author upon reasonable request.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Jan 2027, 3 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 23, 2026
First posted
Oct 16, 2026
StartEst.
Oct 2026
Primary completionEst.
Jan 2027
CompletionEst.
Jan 2027
Last update
Oct 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07878468
Lead sponsor
Second Affiliated Hospital of Nanchang University
Responsible party
Jiaqing Cao (Chief Physician, Second Affiliated Hospital of Nanchang University) — Principal investigator
First posted
Oct 16, 2026
Start date
Oct 2026 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Oct 16, 2026

Study contacts

Jiaqing Cao, Master's degree
Contact
cao.jiaqing@163.com
86-13907008850
Jiaqing Cao
principal investigator · Second Affiliated Hospital of Nanchang University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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