Preoperative Nutritional Support in Esophagectomy or Pancreaticoduodenectomy

NCT ID: NCT00585624

Last Updated: 2015-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

344 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophagectomy Pancreaticoduodenectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Impact Advanced Recovery

Intervention Type DIETARY_SUPPLEMENT

Nutritional supplement

2

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

Group Type PLACEBO_COMPARATOR

No supplement

Intervention Type DIETARY_SUPPLEMENT

No supplement

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Impact Advanced Recovery

Nutritional supplement

Intervention Type DIETARY_SUPPLEMENT

No supplement

No supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 -
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kenneth A Kudsk, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin School of Medicine & Public Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Wisconsin Hospital & Clinics

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

#H-2006-0401

Identifier Type: -

Identifier Source: secondary_id

06206

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

GI Surgery Pre-Operative Nutrition
NCT01471743 COMPLETED NA