NCT00585624

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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
344

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2008

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

October 8, 2015

Status Verified

October 1, 2015

First QC Date

December 26, 2007

Last Update Submit

October 6, 2015

Conditions

EsophagectomyPancreaticoduodenectomy

Keywords

EsophagectomyPancreaticoduodenectomyWhipple

Outcome Measures

Primary Outcomes (1)

  • Postoperative stay in days

    Postoperative stay in hospital & 30 days

Secondary Outcomes (1)

  • Incidence of major complications

    Postoperative stay in hospital & 30 days

Study Arms (2)

1

EXPERIMENTAL

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.

Dietary Supplement: Impact Advanced Recovery

2

PLACEBO COMPARATOR

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

Dietary Supplement: No supplement

Interventions

Impact Advanced RecoveryDIETARY_SUPPLEMENT

Nutritional supplement

1
No supplementDIETARY_SUPPLEMENT

No supplement

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Hospital & Clinics

Madison, Wisconsin, 53792, United States

Location

Study Officials

  • Kenneth A Kudsk, MD

    University of Wisconsin School of Medicine & Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 3, 2008

Study Start

April 1, 2007

Study Completion

October 1, 2009

Last Updated

October 8, 2015

Record last verified: 2015-10

Locations

US(1)