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OpenTrials
Completed

NCT Number: NCT00585624

Preoperative Nutritional Support in Esophagectomy or Pancreaticoduodenectomy

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%.

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Key information

Conditions

Esophagectomy Pancreaticoduodenectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin Hospital & Clinics

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female age 18 years or older of any race-ethnicity who will undergo an elective esophagectomy or pancreaticoduodenectomy.
  • Surgery will be scheduled 5-7 days after consent date -

Exclusion criteria

  • Surgery is urgent or emergent and/or patient would be unable to consume nutritional supplement for 5-7 days
  • Patient is currently receiving enteral (tube) or parenteral (IV) nutritional support
  • Patients with known pre-existing renal failure requiring a low protein diet
  • Patient is unable to drink 3 servings/day of a liquid supplement -

Treatment and study plan

Impact Advanced Recovery

Dietary Supplement

Nutritional supplement

No supplement

Dietary Supplement

No supplement

Primary outcomes

  1. Postoperative stay in days

    Time frame: Postoperative stay in hospital & 30 days

Secondary outcomes

  1. Incidence of major complications

    Time frame: Postoperative stay in hospital & 30 days

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2007
Study completion
2009
First posted
Jan 3, 2008
Registry last updated
Oct 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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