Pancreatic Resection, Malnutrition and Readmission
Primary Purpose
Pancreatic Cancer, Malnutrition
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nestle Impact Advanced Recovery nutritional supplement
Sponsored by
About this trial
This is an interventional supportive care trial for Pancreatic Cancer focused on measuring Whipple
Eligibility Criteria
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
Sites / Locations
- Duke University Medical Center
Outcomes
Primary Outcome Measures
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.
Readmission Rate
Evaluate the impact of a standard perioperative nutritional plan on primary outcome of readmission rate.
Secondary Outcome Measures
Readmission cause
Evaluate the impact of a standard perioperative nutritional plan on readmission cause.
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.
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01947166
Brief Title
Pancreatic Resection, Malnutrition and Readmission
Official Title
Pancreatic Resection, Malnutrition, and Readmission: Assessment and Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Malnutrition
Keywords
Whipple
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
Nestle Impact Advanced Recovery nutritional supplement
Intervention Description
Before Surgery: Consume 1 drink box (8 ounces) three times a day for 5 days (15 servings total) on postoperative day minus 5 through postoperative day 1 in addition to normal diet. After Surgery: Consume 1 drink box (8 ounces) three times a day for 5 days on postoperative day 2 through postoperative day 6.
Primary Outcome Measure Information:
Title
Feasibility of implementing an evidence based perioperative nutritional plan for patients undergoing Whipple as measured by percentage of adherence to nutritional protocol
Description
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.
Time Frame
Up to week 6
Title
Readmission Rate
Description
Evaluate the impact of a standard perioperative nutritional plan on primary outcome of readmission rate.
Time Frame
Up to week 6
Secondary Outcome Measure Information:
Title
Readmission cause
Description
Evaluate the impact of a standard perioperative nutritional plan on readmission cause.
Time Frame
Up to week 6
Title
Length of stay for initial hospitalization and/or readmission
Description
Evaluate the impact of a standard perioperative nutritional plan on length of stay for initial hospitalization and/or readmission.
Time Frame
Up to week 6
Title
Post surgical complications
Description
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.
Time Frame
Up to week 6
Title
Nutritional status
Description
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
Time Frame
Up to week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kara L Penne, RN, MSN, ANP
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pancreatic Resection, Malnutrition and Readmission
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