Preoperative Nutritional Support in Esophagectomy or Panc... | NCT00585624

Studies
Preoperative Nutritional Support in Esophagectomy or Pancreaticoduodenectomy

NCT00585624

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

Oct 8, 2015Estimated

Enrollment

344Estimated

Phase

Not Applicable

Conditions

Esophagectomy
Pancreaticoduodenectomy

Interventions

Impact Advanced Recovery
No supplement

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
#H-2006-0401

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Not provided

Completion Date

Oct 2009Actual

First Submitted Date

Dec 26, 2007

First Submission Date that Met QC Criteria

Dec 26, 2007

First Posted Date

Jan 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2015

Last Update Posted Date

Oct 8, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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%.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

344Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Impact Advanced Recovery	Dietary Supplement	Nutritional supplement	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative stay in days		Postoperative stay in hospital & 30 days

Secondary Outcomes

Measure	Description	Time Frame
Incidence of major complications		Postoperative stay in hospital & 30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kenneth A Kudsk, MD	University of Wisconsin School of Medicine & Public Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin Hospital & Clinics		Madison	Wisconsin	53792	United States