Preoperative Fish Oil PN and Prognosis After Constipation Surgery (FOCP)

March 10, 2026 updated by: Jingbo Chen, Qianfoshan Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

306

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult patients (18-75 years) with slow-transit constipation (STC) or megacolon who meet clinical and diagnostic criteria, are scheduled for elective colon surgery, and have nutritional risk (NRS2002 score >=3). STC is identified based on Rome IV functional constipation criteria with objective evidence of delayed colonic transit and exclusion of outlet obstruction/pelvic floor dyssynergia. Megacolon is diagnosed based on clinical presentation and imaging evidence of colonic dilatation without mechanical obstruction, with exclusion of Hirschsprung disease and other obstructive causes. Participants are enrolled in a prospective multicenter real-world observational study comparing perioperative timing strategies of fish oil-containing parenteral nutrition.

Description

Inclusion Criteria:

  1. Age 18 to 75 years.
  2. Meets diagnostic criteria for slow-transit constipation (STC) or megacolon and is scheduled for elective colon surgery.
  3. Nutritional Risk Screening 2002 (NRS2002) score >=3.
  4. 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).
  5. Voluntarily participates in the study and provides signed informed consent.

Exclusion Criteria:

  1. Mental disorders or other conditions that prevent cooperation with treatment or follow-up.
  2. 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.
  3. Contraindications to surgery or parenteral nutrition.
  4. Concurrent enrollment in another study.
  5. No baseline data available before initiation of nutritional support treatment.
  6. Any other condition judged by the investigator to make the participant unsuitable for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre+Post-op Fish Oil PN Group
Participants who receive parenteral nutrition (PN) with a fish oil-containing lipid emulsion before elective colon surgery (for at least 3 days preoperatively, based on clinical condition) and continue PN after surgery as part of routine clinical care, including perioperative use around the preoperative fasting period to maintain energy supply. Postoperative PN is initiated on postoperative day 1.
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, participants receive a normal diet preoperatively. In both cohorts, PN is initiated on postoperative day 1. Postoperative nutritional management follows the same protocol in both cohorts, with gradual advancement toward energy/protein targets and progressive transition to enteral nutrition/oral nutritional supplements (EN/ONS), with PN tapering and discontinuation when EN/ONS provides adequate energy intake.
Post-op Only Fish Oil PN Group
Participants who initiate parenteral nutrition (PN) with a fish oil-containing lipid emulsion only after elective colon surgery as part of routine clinical care. Before surgery, participants receive a normal diet and do not receive the study PN strategy preoperatively. Postoperative PN is initiated on postoperative day 1.
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, participants receive a normal diet preoperatively. In both cohorts, PN is initiated on postoperative day 1. Postoperative nutritional management follows the same protocol in both cohorts, with gradual advancement toward energy/protein targets and progressive transition to enteral nutrition/oral nutritional supplements (EN/ONS), with PN tapering and discontinuation when EN/ONS provides adequate energy intake.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative complication rate
Time Frame: From postoperative period through 6 months after surgery
From postoperative period through 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qianfoshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YXLL-KY-2026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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