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Pancreatic Resection, Malnutrition and Readmission

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ClinicalTrials.gov Identifier: NCT01947166
Recruitment Status : Completed
First Posted : September 20, 2013
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Pancreatic Cancer Malnutrition Dietary Supplement: Nestle Impact Advanced Recovery nutritional supplement

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pancreatic Resection, Malnutrition, and Readmission: Assessment and Prevention
Study Start Date : December 2013
Primary Completion Date : June 2016
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Dietary Supplement: Nestle Impact Advanced Recovery nutritional supplement
    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.

Outcome Measures

Primary Outcome Measures :
  1. Feasibility of implementing an evidence based perioperative nutritional plan for patients undergoing Whipple as measured by percentage of adherence to nutritional protocol [ Time Frame: 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.

  2. Readmission Rate [ Time Frame: Up to week 6 ]
    Evaluate the impact of a standard perioperative nutritional plan on primary outcome of readmission rate.


Secondary Outcome Measures :
  1. Readmission cause [ Time Frame: Up to week 6 ]
    Evaluate the impact of a standard perioperative nutritional plan on readmission cause.

  2. Length of stay for initial hospitalization and/or readmission [ Time Frame: Up to week 6 ]
    Evaluate the impact of a standard perioperative nutritional plan on length of stay for initial hospitalization and/or readmission.

  3. Post surgical complications [ Time Frame: 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.

  4. Nutritional status [ Time Frame: 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


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947166


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Kara L Penne, RN, MSN, ANP Duke University Health System
More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01947166     History of Changes
Other Study ID Numbers: Pro00047214
First Posted: September 20, 2013    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016

Keywords provided by Duke University:
Whipple

Additional relevant MeSH terms:
Pancreatic Neoplasms
Malnutrition
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Nutrition Disorders