Perioperative Nutrition in Gastric Bypass Surgery

NCT ID: NCT00549237

Last Updated: 2013-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-11-30

Brief Summary

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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

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Outcome measures:

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

Conditions

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Postoperative Complications Gastric Bypass

Keywords

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RYGBP Early nutrition Lean body mass Length of stay Body Composition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nutrition

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

Group Type ACTIVE_COMPARATOR

Glucose load (Nutricia)

Intervention Type DIETARY_SUPPLEMENT

Pre-operative glucose load: 800 ml of PreOp (Nutricia) 12 h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery

Post operative early enteral feeding

Intervention Type OTHER

Enteral feeding starting 6 hours post surgery

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Post operative early enteral feeding

Enteral feeding starting 6 hours post surgery

Intervention Type OTHER

Other Intervention Names

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PreOp, Nutricia

Eligibility Criteria

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Inclusion Criteria

* RYGBP surgery planned
* Age over 18
* Informed consent

Exclusion Criteria

* Previous bariatric surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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University Hospital, Geneva

Principal Investigators

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Dan E Azagury, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

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Hôpitaux Universitaires Genève

Geneva, Canton of Geneva, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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CER 07 - 096

Identifier Type: -

Identifier Source: org_study_id