Nutritional Intervention Implication in Enhanced Recovery After Surgery for Whipple Procedure
Recruiting · NCT07560540 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Veterinary and Animal Sciences, Lahore - Pakistan
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Malignancy of;
- Distal common bile duct
- Pancreatic head
- Periampullary
- Duodenal
- Patients scheduled for elective Whipple's procedure (laparoscopic and open)
- Age 18 and above
Exclusion criteria
- 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
Where it is running
1 location listed.
- Shalamar Hospital - Lahore, Pakistan