Pancreatic Resection, Malnutrition and Readmission

Not Applicable

Completed

• Conditions: Pancreatic Cancer; Malnutrition

• Registration Number: NCT01947166
• Lead Sponsor: Duke University

Brief Summary

The Whipple procedure is associated with increased readmission rates for infection, pancreatic leak, and failure to thrive/malnutrition. The purpose of this study is to develop an evidence based perioperative nutrition plan to improve patient outcomes. The study has two specific aims including evaluation of feasibility of implementing an evidence based perioperative nutritional plan for patients undergoing Whipple and evaluation of impact of a standard perioperative nutritional plan on primary outcome of readmission rate and secondary outcomes of readmission cause, length of stay for initial hospitalization and/or readmission, post surgical complications (surgical site infections, pancreatic leak, sepsis, delayed gastric emptying), and nutritional status (PG-Subject Generated Assessment scores, BMI, albumin, pre-albumin, and method of oral intake). Categorical variables including readmission rate, readmission cause, post-surgical complications and nutritional status will be compared by chi-square test between intervention and control group. Length of stay for initial hospitalization and readmission will be compared by non parametric Wilcoxon test between two groups. Descriptive statistics will be used to describe the sample. There are no risks to the study participants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-23
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-20
• Study Start: 2013-12
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-28
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Adult patients (>18 years of age)at Duke Cancer Center
• Malignant pancreatic disease, undergoing surgical resection with pancreaticoduodenectomy (Whipple)
• Able to read and speak English.

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Exclusion Criteria

• Patients receiving preoperative enteral nutrition
• Inability to tolerate preoperative oral intake

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Readmission Rate	Up to week 6	Evaluate the impact of a standard perioperative nutritional plan on primary outcome of readmission rate.
Feasibility of implementing an evidence based perioperative nutritional plan for patients undergoing Whipple as measured by percentage of adherence to nutritional protocol	Up to week 6	Evaluate the feasibility of implementing an evidence based perioperative nutritional plan for patients undergoing Whipple by outcomes of: 1)admission rates, 2) admission causes 3)percentage of adherence to nutritional protocol 4) length of stay 5) reported symptoms (nausea, vomiting, diarrhea), 6) postsurgical complications 7) nutritional status preoperative visit between days 2 - 5 postoperatively, on the day of discharge, and at follow up visits at weeks 1, 3 and 6.

Secondary Outcome Measures

Name	Time	Method
Post surgical complications	Up to week 6	Evaluate the impact of a standard perioperative nutritional plan on post surgical complications (surgical site infections, pancreatic leak, sepsis, delayed gastric emptying) between days 2 - 5 postoperatively, on the day of discharge, and at follow up visits at weeks 1, 3 and 6.
Readmission cause	Up to week 6	Evaluate the impact of a standard perioperative nutritional plan on readmission cause.
Nutritional status	Up to week 6	Evaluate the impact of a standard perioperative nutritional plan on nutritional status (PG-Subject Generated Assessment scores, BMI, albumin, pre-albumin, and method of oral intake) at preoperative visit, between days 2 - 5 postoperatively, on the day of discharge, and at follow up visits at weeks 1, 3 and 6
Length of stay for initial hospitalization and/or readmission	Up to week 6	Evaluate the impact of a standard perioperative nutritional plan on length of stay for initial hospitalization and/or readmission.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States