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临床试验/NCT07560540
NCT07560540招募中不适用

Implication of Nutritional Intervention in Enhanced Recovery After Surgery for Whipple Procedure/Pylorus Preserving Pancreatoduodenectomy

University of Veterinary and Animal Sciences, Lahore - Pakistan1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Evidence-based data for ERAS focusing on nutritional recommendations in Whipple's Procedure/PPPD will be generated for the Pakistani population.

研究概览

简要总结

The objective of this research is to assess the impact of personalized nutritional intervention on postoperative complications and length of stay in Whipple's patients via assessing the parameters related to body composition, nutritional status, weight maintenance, biochemical profile (LFTs, RFTs, CBC, CRP, serum electrolytes, coagulation profile and HbA1c) and muscle preservation postoperatively. Moreover, enhanced recovery after surgery (ERAS) guidelines in Whipple's patients will also be monitored. Exactly 20 patients undergoing Whipple's Procedure/PPPD in 1 year will be recruited for the study. Medical nutrition therapy will include energy intake of 25- 30 Kcal/kg body weight and protein 1.2-1.5g/kg body weight. Enteral nutrition and parenteral nutrition will be given accordingly. After discharge, patients receiving chemotherapy and patients not receiving chemotherapy will be nutritionally intervened accordingly. Follow-ups will be done in the 2nd week, 3rd month and 6th month after surgery. Data will be analyzed using SPSS version 27. To assess the significant difference among study groups t-test, repeated measure analysis of variance (ANOVA) and regression model will be applied. The level of significance will be kept at 5%. t-test for treatment groups.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Malignancy of;
  • Distal common bile duct
  • Pancreatic head
  • Periampullary
  • Patients scheduled for elective Whipple's procedure (laparoscopic and open)
  • Age 18 and above

排除标准

  • Patients undergoing Whipple's procedure for reasons other than malignancy
  • Patients undergoing emergency procedures
  • Patients with significant preoperative complications prohibiting oral intake
  • Age below 18

研究组 & 干预措施

Treatment

Experimental

干预措施: Nutrition Intervention (Other)

结局指标

主要结局

Evidence-based data for ERAS focusing on nutritional recommendations in Whipple's Procedure/PPPD will be generated for the Pakistani population.

时间窗: 2 years

The research and evidence-based data for ERAS focusing on nutritional recommendations in Whipple's Procedure/PPPD will be generated for the Pakistani population. The impact of the nutritional intervention with the available resources will be measured by Body Composition Analysis, Patient Generated Subjective Global Assessment and Biochemical Profiling.

次要结局

未报告次要终点

研究者

发起方
University of Veterinary and Animal Sciences, Lahore - Pakistan
申办方类型
Other
责任方
Sponsor

研究点 (1)

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