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Perioperative Nutrition in Gastric Bypass Surgery

Primary Purpose

Postoperative Complications, Gastric Bypass

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Glucose load (Nutricia)
Post operative early enteral feeding
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Complications focused on measuring RYGBP, Early nutrition, Lean body mass, Length of stay, Body Composition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • RYGBP surgery planned
  • Age over 18
  • Informed consent

Exclusion Criteria:

  • Previous bariatric surgery

Sites / Locations

  • Hôpitaux Universitaires Genève

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Nutrition

Control

Arm Description

Pre-operative Glucose load and post-operative immediate enteral nutrition

No pre-operative glucose load. No early post-operative nutrition

Outcomes

Primary Outcome Measures

Post-operative body mass composition

Secondary Outcome Measures

Post-operative complications
Length of stay

Full Information

First Posted
October 24, 2007
Last Updated
September 5, 2013
Sponsor
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT00549237
Brief Title
Perioperative Nutrition in Gastric Bypass Surgery
Official Title
Perioperative Nutrition in Gastric Bypass Surgery for Morbid Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Geneva

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Outcome measures: Lean body mass Length of hospital stay Weight loss Postoperative complications Cost

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Gastric Bypass
Keywords
RYGBP, Early nutrition, Lean body mass, Length of stay, Body Composition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutrition
Arm Type
Active Comparator
Arm Description
Pre-operative Glucose load and post-operative immediate enteral nutrition
Arm Title
Control
Arm Type
No Intervention
Arm Description
No pre-operative glucose load. No early post-operative nutrition
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucose load (Nutricia)
Other Intervention Name(s)
PreOp, Nutricia
Intervention Description
Pre-operative glucose load: 800 ml of PreOp (Nutricia) 12 h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery
Intervention Type
Other
Intervention Name(s)
Post operative early enteral feeding
Intervention Description
Enteral feeding starting 6 hours post surgery
Primary Outcome Measure Information:
Title
Post-operative body mass composition
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Post-operative complications
Time Frame
30 days
Title
Length of stay
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: RYGBP surgery planned Age over 18 Informed consent Exclusion Criteria: Previous bariatric surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan E Azagury, MD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpitaux Universitaires Genève
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

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Perioperative Nutrition in Gastric Bypass Surgery

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