Perioperative Nutrition in Gastric Bypass Surgery
September 5, 2013 updated by: University Hospital, Geneva
Perioperative Nutrition in Gastric Bypass Surgery for Morbid Obesity
The aim of this study is to demonstrate the influence of peri-operative nutrition on the preservation of lean body mass after gastric bypass, as well as it's influence on postoperative complications.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Outcome measures:
- Lean body mass
- Length of hospital stay
- Weight loss
- Postoperative complications
- Cost
Study Type
Interventional
Enrollment (Actual)
200
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
-
-
-
Geneva, Switzerland, 1211
- Hôpitaux Universitaires Genève
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-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- RYGBP surgery planned
- Age over 18
- Informed consent
Exclusion Criteria:
- Previous bariatric surgery
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Nutrition
Pre-operative Glucose load and post-operative immediate enteral nutrition
|
Pre-operative glucose load: 800 ml of PreOp (Nutricia) 12 h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery
Other Names:
Enteral feeding starting 6 hours post surgery
|
|
No Intervention: Control
No pre-operative glucose load.
No early post-operative nutrition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Post-operative body mass composition
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Length of stay
Time Frame: 2 weeks
|
2 weeks
|
|
Post-operative complications
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dan E Azagury, MD, University Hospital, Geneva
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
November 1, 2007
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
October 24, 2007
First Submitted That Met QC Criteria
October 24, 2007
First Posted (Estimate)
October 25, 2007
Study Record Updates
Last Update Posted (Estimate)
September 6, 2013
Last Update Submitted That Met QC Criteria
September 5, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CER 07 - 096
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.