Preoperative Nutritional Support in Esophagectomy or Pancreaticoduodenectomy - Full Text View

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00585624

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

MedlinePlus related topics: Dietary Supplements Nutritional Support

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Parallel Assignment
Official Title:	Preoperative Nutritional Support Reduces Postoperative Stay and Incidence of Complications in Patients Undergoing an Esophagectomy or Pancreaticoduodenectomy

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
1: Experimental 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
2: Placebo Comparator 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:

Male or female age 18 years or older of any race-ethnicity who will undergo an elective esophagectomy or pancreaticoduodenectomy.
Surgery will be scheduled 5-7 days after consent date -

Exclusion Criteria:

Surgery is urgent or emergent and/or patient would be unable to consume nutritional supplement for 5-7 days
Patient is currently receiving enteral (tube) or parenteral (IV) nutritional support
Patients with known pre-existing renal failure requiring a low protein diet
Patient is unable to drink 3 servings/day of a liquid supplement -

Contacts and Locations

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

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

Keywords provided by University of Wisconsin, Madison:

Esophagectomy
Pancreaticoduodenectomy
Whipple

ClinicalTrials.gov processed this record on January 16, 2009