Preoperative Nutritional Support in Esophagectomy or Pancreaticoduodenectomy

Not Applicable

Completed

• Conditions: Esophagectomy; Pancreaticoduodenectomy
• Interventions: Dietary Supplement: Impact Advanced Recovery; Dietary Supplement: No supplement

• Registration Number: NCT00585624
• Lead Sponsor: 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%.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2008-01-03
• Study Completion: 2009-10
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-06
• Last Update Posted: 2015-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 344

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Impact Advanced Recovery	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.
2	No supplement	Standard Care: Food, beverages, or supplements as recommended or desired by patient or primary care/surgical team.

Primary Outcome Measures

Name	Time	Method
Postoperative stay in days	Postoperative stay in hospital & 30 days

Secondary Outcome Measures

Name	Time	Method
Incidence of major complications	Postoperative stay in hospital & 30 days

Trial Locations

Locations (1)

University of Wisconsin Hospital & Clinics; 🇺🇸 Madison, Wisconsin, United States