Preoperative Nutritional Support in Esophagectomy or Pancreaticoduodenectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of Wisconsin, Madison.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00585624
First received: December 26, 2007
Last updated: June 6, 2008
Last verified: June 2008
  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: 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
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585624

Contacts
Contact: Cassandra E Kight, PhD, RD 608-265-6354 kight@surgery.wisc.edu
Contact: Caitlin Curtis, PharmD 608-265-1746 ccurtis@uwhealth.org

Locations
United States, Wisconsin
University of Wisconsin Hospital & Clinics Recruiting
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

No publications provided

Responsible Party: Kenneth A. Kudsk, M.D., University of Wisconsin School of Medicine & Public Health
ClinicalTrials.gov Identifier: NCT00585624     History of Changes
Other Study ID Numbers: 06206, #H-2006-0401
Study First Received: December 26, 2007
Last Updated: June 6, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 26, 2014