Impact of Preoperative Fish Oil-Containing Parenteral Nutrition on Prognosis in Patients Undergoing Surgery for Constipation: A Prospective, Multicenter, Real-World Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 306
- 主要终点
- Postoperative complication rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 >=
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Fish oil-containing total parenteral nutrition (PN) (Drug)
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.
干预措施: Fish oil-containing total parenteral nutrition (PN) (Drug)
结局指标
主要结局
Postoperative complication rate
时间窗: From postoperative period through 6 months after surgery
次要结局
未报告次要终点
研究者
Jingbo Chen
Principal Investigator
Qianfoshan Hospital