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Sponsored by: |
University of Wisconsin, Madison |
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Information provided by: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00585624 |
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: | 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 |
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
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cassandra E Kight, PhD, RD | 608-265-6354 | kight@surgery.wisc.edu |
Contact: Caitlin Curtis, PharmD | 608-265-1746 | ccurtis@uwhealth.org |
United States, Wisconsin | |
University of Wisconsin Hospital & Clinics | Recruiting |
Madison, Wisconsin, United States, 53792 |
Principal Investigator: | Kenneth A Kudsk, MD | University of Wisconsin School of Medicine & Public Health |
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 |
Esophagectomy Pancreaticoduodenectomy Whipple |