Perioperative Nutrition in Gastric Bypass Surgery

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00549237
First received: October 24, 2007
Last updated: September 5, 2013
Last verified: August 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-operative complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Length of stay [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • RYGBP surgery planned
  • Age over 18
  • Informed consent

Exclusion Criteria:

  • Previous bariatric surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Principal investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00549237     History of Changes
Other Study ID Numbers: CER 07 - 096
Study First Received: October 24, 2007
Last Updated: September 5, 2013
Health Authority: Switzerland: Federal Office of Public Health

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

ClinicalTrials.gov processed this record on April 17, 2014