Pancreatic Resection, Malnutrition and Readmission

Pancreatic Resection, Malnutrition, and Readmission: Assessment and Prevention

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer; Malnutrition
• Intervention / Treatment: Dietary supplement: Nestle Impact Advanced Recovery nutritional supplement

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of implementing an evidence based perioperative nutritional plan for patients undergoing Whipple as measured by percentage of adherence to nutritional protocol	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.	Up to week 6
Readmission Rate	Evaluate the impact of a standard perioperative nutritional plan on primary outcome of readmission rate.	Up to week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission cause	Evaluate the impact of a standard perioperative nutritional plan on readmission cause.	Up to week 6
Length of stay for initial hospitalization and/or readmission	Evaluate the impact of a standard perioperative nutritional plan on length of stay for initial hospitalization and/or readmission.	Up to week 6
Post surgical complications	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.	Up to week 6
Nutritional status	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	Up to week 6

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Kara L Penne, RN, MSN, ANP, Duke Health

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: August 23, 2013
• First Submitted That Met QC Criteria: September 17, 2013
• First Posted (Estimate): September 20, 2013

Study Record Updates

• Last Update Posted (Estimate): November 29, 2016
• Last Update Submitted That Met QC Criteria: November 28, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Whipple
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: Pro00047214