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Not yet recruiting NCT07470892

Preoperative Fish Oil PN and Prognosis After Constipation Surgery

Observational Constipation Slow Transit Constipation Megacolon

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fish oil-containing total parenteral nutrition (PN).
Who it may be relevant to
Registry conditions: Constipation, Slow Transit Constipation, Megacolon. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impact of Preoperative Fish Oil-Containing Parenteral Nutrition on Prognosis in Patients Undergoing Surgery for Constipation: A Prospective, Multicenter, Real-World Study

Overview

This is a prospective, multicenter, real-world observational study to evaluate the impact of perioperative parenteral nutrition (PN) with fish oil-containing lipid emulsion on outcomes in adult patients with constipation undergoing elective colon surgery. The study will compare two clinical nutrition strategies: (1) PN with fish oil-containing lipid emulsion started before surgery and continued after surgery, and (2) PN with fish oil-containing lipid emulsion started only after surgery. Eligible participants are adults (18-75 years) with slow-transit constipation (STC) or megacolon who are scheduled for elective colon surgery and have nutritional risk (NRS2002 score \>=3). The primary objective is to compare the incidence of postoperative complications between these two PN timing strategies. Secondary objectives include comparison of perioperative nutritional status, postoperative inflammatory status, prognosis, and safety outcomes. This study will collect and analyze clinical data, laboratory indicators, perioperative recovery outcomes, follow-up assessments, and safety information in routine clinical practice. Outcomes include postoperative complication rates, changes in nutritional and inflammatory markers, bowel function recovery, length of hospital stay, constipation-related symptoms, quality of life, and adverse events. No experimental intervention will be assigned as part of this observational study. The planned sample size is 306 participants. The findings may help optimize perioperative nutritional support strategies for patients with constipation undergoing surgery.

Interventions

  • Drug Fish oil-containing total parenteral nutrition (PN)
    Nutritional support is based on an all-in-one parenteral nutrition (PN) formulation containing omega-3 triglycerides (fish oil, 2%), medium/long-chain lipid emulsion, amino acids, and glucose. In the preoperative observation cohort, participants receive fish oil-containing PN in addition to a normal diet for \>=3 days before surgery (duration determined by clinical condition), including PN administration around the preoperative fasting period to maintain energy supply. In the comparison cohort,

Primary outcome measures

  • Postoperative complication rate [Time frame: From postoperative period through 6 months after surgery]

Eligibility criteria

Inclusion criteria

  • Age 18 to 75 years.
  • Meets diagnostic criteria for slow-transit constipation (STC) or megacolon and is scheduled for elective colon surgery.
  • Nutritional Risk Screening 2002 (NRS2002) score >=3.
  • Receives fish oil-containing parenteral nutrition (PN) for >=3 days preoperatively or initiates PN for the first time postoperatively (according to the study cohort definition).
  • Voluntarily participates in the study and provides signed informed consent.

Exclusion criteria

  • Mental disorders or other conditions that prevent cooperation with treatment or follow-up.
  • Pregnant or breastfeeding women, women planning pregnancy / in a pre-pregnancy state, or women with a clear intention to become pregnant during the perioperative period or follow-up.
  • Contraindications to surgery or parenteral nutrition.
  • Concurrent enrollment in another study.
  • No baseline data available before initiation of nutritional support treatment.
  • Any other condition judged by the investigator to make the participant unsuitable for this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07470892 · YXLL-KY-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗