Preoperative Nutritional Support in Esophagectomy or Pancreaticoduodenectomy

University of Wisconsin (UW)

Status: Completed

Conditions: Esophagectomy; Pancreaticoduodenectomy

Treatments: Dietary Supplement: Impact Advanced Recovery; Dietary Supplement: No supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT00585624

#H-2006-0401

06206

Details and patient eligibility

About

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%.

Enrollment: 344 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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344 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Impact Advanced Recovery

2

Placebo Comparator group

Description:

Standard Care: Food, beverages, or supplements as recommended or desired by patient or primary care/surgical team.

Treatment:

Dietary Supplement: No supplement