Preoperative Nutritional Support in Esophagectomy or Pancreaticoduodenectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00585624
First received: December 26, 2007
Last updated: October 6, 2015
Last verified: October 2015

December 26, 2007
October 6, 2015
April 2007
Not Provided
Postoperative stay in days [ Time Frame: Postoperative stay in hospital & 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00585624 on ClinicalTrials.gov Archive Site
Incidence of major complications [ Time Frame: Postoperative stay in hospital & 30 days ] [ Designated as safety issue: No ]
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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
344
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 -
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00585624
06206, #H-2006-0401
No
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