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Preoperative Nutritional Support in Esophagectomy or Pancreaticoduodenectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00585624
First Posted: January 3, 2008
Last Update Posted: October 8, 2015
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.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
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
Esophagectomy Pancreaticoduodenectomy Dietary Supplement: Impact Advanced Recovery Dietary Supplement: No supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Incidence of major complications [ Time Frame: Postoperative stay in hospital & 30 days ]

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

  Eligibility

Information from the National Library of Medicine

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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:

  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 -
  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): NCT00585624


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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00585624     History of Changes
Other Study ID Numbers: 06206
#H-2006-0401
First Submitted: December 26, 2007
First Posted: January 3, 2008
Last Update Posted: October 8, 2015
Last Verified: October 2015

Keywords provided by University of Wisconsin, Madison:
Esophagectomy
Pancreaticoduodenectomy
Whipple