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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complication rate | From postoperative period through 6 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| ID | Term |
|---|---|
| D003248 | Constipation |
| D008531 | Megacolon |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003108 | Colonic Diseases |
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| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |