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Preoperative Nutritional Support in Esophagectomy or Pancreaticoduodenectomy

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ClinicalTrials.gov Identifier: NCT00585624
Recruitment Status : Completed
First Posted : January 3, 2008
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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 or disease Intervention/treatment Phase
Esophagectomy Pancreaticoduodenectomy Dietary Supplement: Impact Advanced Recovery Dietary Supplement: No supplement Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 344 participants
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
Study Start Date : April 2007
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Postoperative stay in days [ Time Frame: Postoperative stay in hospital & 30 days ]

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


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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 -

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

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

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