Preoperative Nutritional Support in Esophagectomy or Pancreaticoduodenectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00585624
Recruitment Status : Completed
First Posted : January 3, 2008
Last Update Posted : October 8, 2015
Information provided by (Responsible Party):
University of Wisconsin, Madison

December 26, 2007
January 3, 2008
October 8, 2015
April 2007
Not Provided
Postoperative stay in days [ Time Frame: Postoperative stay in hospital & 30 days ]
Same as current
Complete list of historical versions of study NCT00585624 on Archive Site
Incidence of major complications [ Time Frame: Postoperative stay in hospital & 30 days ]
Same as current
Not Provided
Not Provided
Preoperative Nutritional Support in Esophagectomy or Pancreaticoduodenectomy
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%.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Esophagectomy
  • Pancreaticoduodenectomy
  • Dietary Supplement: Impact Advanced Recovery
    Nutritional supplement
  • Dietary Supplement: No supplement
    No supplement
  • 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.
    Intervention: Dietary Supplement: Impact Advanced Recovery
  • Placebo Comparator: 2
    Standard Care: Food, beverages, or supplements as recommended or desired by patient or primary care/surgical team.
    Intervention: Dietary Supplement: No supplement
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2009
Not Provided

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 -
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Kenneth A Kudsk, MD University of Wisconsin School of Medicine & Public Health
University of Wisconsin, Madison
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP