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

  • Switzerland
      • Geneva, Switzerland, 1211
        • Hôpitaux Universitaires Genève

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
Dietary supplement: Glucose load (Nutricia)
Pre-operative glucose load: 800 ml of PreOp (Nutricia) 12 h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery
Other Names:
  • PreOp, Nutricia
Other: Post operative early enteral feeding
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

University Hospital, Geneva

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

Keywords

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.

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