Preoperative Nutritional Support in Esophagectomy or Pancreaticoduodenectomy

This study has been completed.
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: December 26, 2007
Last updated: October 6, 2015
Last verified: October 2015

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%.

Condition Intervention
Dietary Supplement: Impact Advanced Recovery
Dietary Supplement: No supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Preoperative Nutritional Support Reduces Postoperative Stay and Incidence of Complications in Patients Undergoing an Esophagectomy or Pancreaticoduodenectomy

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Postoperative stay in days [ Time Frame: Postoperative stay in hospital & 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of major complications [ Time Frame: Postoperative stay in hospital & 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 344
Study Start Date: April 2007
Study Completion Date: October 2009
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 -
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Please refer to this study by its identifier: NCT00585624

United States, Wisconsin
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Kenneth A Kudsk, MD University of Wisconsin School of Medicine & Public Health
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison Identifier: NCT00585624     History of Changes
Other Study ID Numbers: 06206, #H-2006-0401
Study First Received: December 26, 2007
Last Updated: October 6, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Whipple processed this record on October 09, 2015