Preoperative Nutritional Support in Esophagectomy or Pancreaticoduodenectomy

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT00585624
• Collaborator: (none)
• Enrollment: 344
• Location: 1
• Arms: 2
• Duration (Months): 30
• Patients Per Site Per Month: 11.5

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Apr 1, 2007
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Postoperative stay in days [Postoperative stay in hospital & 30 days]

Secondary Outcome Measures

1. Incidence of major complications [Postoperative stay in hospital & 30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00585624
• Other Study ID Numbers: 06206; #H-2006-0401
• First Posted: Jan 3, 2008
• Last Update Posted: Oct 8, 2015
• Last Verified: Oct 1, 2015

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

Study Results

No Results Posted as of Oct 8, 2015