Preoperative Nutritional Support in Esophagectomy or Pancreaticoduodenectomy

October 6, 2015 updated by: University of Wisconsin, Madison

Preoperative Nutritional Support Reduces Postoperative Stay and Incidence of Complications in Patients Undergoing an Esophagectomy or Pancreaticoduodenectomy

We are proposing to evaluate the benefit of preoperative nutritional support with Impact Advanced Recovery in the most vulnerable group of elective gastrointestinal surgery patients who may experience a complication, esophagus and pancreas resections, and hypothesize that oral supplementation with 3 servings (0.75 L) Impact Advanced Recovery will reduce postoperative stay by 10-20% and reduce the incidence of major complications by 25%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

344

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital & Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  1. Male or female age 18 years or older of any race-ethnicity who will undergo an elective esophagectomy or pancreaticoduodenectomy.
  2. Surgery will be scheduled 5-7 days after consent date -

Exclusion Criteria:

  1. Surgery is urgent or emergent and/or patient would be unable to consume nutritional supplement for 5-7 days
  2. Patient is currently receiving enteral (tube) or parenteral (IV) nutritional support
  3. Patients with known pre-existing renal failure requiring a low protein diet
  4. Patient is unable to drink 3 servings/day of a liquid supplement -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Supplement: 3 servings/day of Impact Advanced Recovery in addition to regular food or any other supplements recommended or desired by patient or primary care/surgical team.
Dietary supplement: Impact Advanced Recovery
Nutritional supplement
Placebo Comparator: 2
Standard Care: Food, beverages, or supplements as recommended or desired by patient or primary care/surgical team.
Dietary supplement: No supplement
No supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative stay in days
Time Frame: Postoperative stay in hospital & 30 days
Postoperative stay in hospital & 30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of major complications
Time Frame: Postoperative stay in hospital & 30 days
Postoperative stay in hospital & 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Kenneth A Kudsk, MD, University of Wisconsin School of Medicine & Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

December 26, 2007

First Posted (Estimate)

January 3, 2008

Study Record Updates

Last Update Posted (Estimate)

October 8, 2015

Last Update Submitted That Met QC Criteria

October 6, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 06206
  • #H-2006-0401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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