Preoperative Oral Nutritional Supplement (preOP Booster) in Visceral Surgery
December 5, 2008 updated by: Fresenius Kabi
Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (preOP Booster) Versus Placebo in Visceral Surgery
The purpose of this pilot study is to investigate the effect of an oral nutritional supplement (preOP booster) versus placebo regarding metabolic criteria in patients undergoing elective pancreaticoduodenectomy.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Milan, Italy, 20132
- Università Salute-Vita San Raffaele,
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Elective pancreaticoduodenectomy
Exclusion Criteria:
- Concomitant chemotherapy
- Severe malnutrition (SGA score C)
- Conditions affecting gastric emptying
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: preOP booster
|
3x1 dosage pre-operatively
|
|
Placebo Comparator: preOP booster placebo
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3x1 dosage pre-operatively
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
laboratory measurements: total endogenous antioxidant capacity, free radicals, CRP;
Time Frame: up to 30 days after surgery
|
up to 30 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
postoperative complications, pre- and postoperative discomfort (well-being), muscle strength at 7 days post-op, length of stay (hospital / ICU), ambulation time, gastro intestinal tolerance
Time Frame: up to 30 days after surgery
|
up to 30 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marco Braga, Prof MD, Università Salute-Vita San Raffaele, Milan, Italy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
July 16, 2007
First Submitted That Met QC Criteria
July 17, 2007
First Posted (Estimate)
July 18, 2007
Study Record Updates
Last Update Posted (Estimate)
December 8, 2008
Last Update Submitted That Met QC Criteria
December 5, 2008
Last Verified
November 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- N-POB-03-IT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.