Preoperative Nutritional Support in Esophagectomy or Pancreaticoduodenectomy

Pancreaticoduodenectomy Clinical Trial

Official title:

Preoperative Nutritional Support Reduces Postoperative Stay and Incidence of Complications in Patients Undergoing an Esophagectomy or Pancreaticoduodenectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00585624
• Other study ID #: 06206
• Secondary ID: #H-2006-0401
• Status: Completed
• Phase: N/A
• First received: December 26, 2007
• Last updated: October 6, 2015
• Start date: April 2007
• Est. completion date: October 2009

Study information

• Verified date: October 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 344
• Est. completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Esophagectomy
• Pancreaticoduodenectomy

Intervention

Dietary Supplement:
• Impact Advanced Recovery
Nutritional supplement
• No supplement
No supplement

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital & Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative stay in days		Postoperative stay in hospital & 30 days	No
Secondary	Incidence of major complications		Postoperative stay in hospital & 30 days	No