Preoperative Fish Oil PN and Prognosis After Constipation Surgery

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.

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Key information

Conditions

Constipation Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Megacolon Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Slow Transit Constipation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fish oil-containing total parenteral nutrition (PN)

Drug

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.

Primary outcomes

Postoperative complication rate

Time frame: From postoperative period through 6 months after surgery

Sponsors and collaborators

Lead sponsor

Qianfoshan Hospital

Other

Registry information

Official study title

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

Acronym: FOCP

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2029
First posted: Mar 13, 2026
Registry last updated: Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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