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Perioperative Nutrition in Gastric Bypass Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00549237
First Posted: October 25, 2007
Last Update Posted: September 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Geneva
  Purpose
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.

Condition Intervention
Postoperative Complications Gastric Bypass Dietary Supplement: Glucose load (Nutricia) Other: Post operative early enteral feeding

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Perioperative Nutrition in Gastric Bypass Surgery for Morbid Obesity

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Post-operative body mass composition [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Post-operative complications [ Time Frame: 30 days ]
  • Length of stay [ Time Frame: 2 weeks ]

Enrollment: 200
Study Start Date: November 2007
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

Detailed Description:

Outcome measures:

  • Lean body mass
  • Length of hospital stay
  • Weight loss
  • Postoperative complications
  • Cost
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • RYGBP surgery planned
  • Age over 18
  • Informed consent

Exclusion Criteria:

  • Previous bariatric surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00549237


Locations
Switzerland
Hôpitaux Universitaires Genève
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Dan E Azagury, MD Geneva University Hospital
  More Information

Responsible Party: Principal investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00549237     History of Changes
Other Study ID Numbers: CER 07 - 096
First Submitted: October 24, 2007
First Posted: October 25, 2007
Last Update Posted: September 6, 2013
Last Verified: August 2013

Keywords provided by University Hospital, Geneva:
RYGBP
Early nutrition
Lean body mass
Length of stay
Body Composition

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes