Preoperative Fish Oil PN and Prognosis After Constipation Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorQianfoshan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Fish oil-containing total parenteral nutrition (PN)
DrugNutritional 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.
Treatment groups
306 Participants
are divided into 2 treatment groupsGroup A: Pre+Post-op Fish Oil PN Group1 intervention
Group B: Post-op Only Fish Oil PN Group1 intervention
Trial outcomes
Primary outcomes
1
Postoperative complication rate
Time frame
From postoperative period through 6 months after surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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