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Randomized Trial of Preoperative Diets Before Bariatric Surgery

Primary Purpose

Morbid Obesity, Bariatric Surgery, Gastric Bypass

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Standard diet versus standard VLCD (Prodimed)
Sponsored by
Lievensberg Ziekenhuis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Gastric bypass, Preoperative diet, Prodimed

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • morbid obesity according to IFSO criteria

Exclusion Criteria:

  • previous bariatric or gastric surgery
  • severe psychiatric disorders

Sites / Locations

  • Bariatric Centre Lievensberg hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Diet

Prodimed

Arm Description

New developed diet

Standard VLCD

Outcomes

Primary Outcome Measures

Preoperative weight loss before bariatric surgery
Weight loss in kg before operation

Secondary Outcome Measures

- operation time - blood loss - difficulty of procedure - short term complications - acceptance of diets according to patients
Measured by VAS, diet books and questionnaires

Full Information

First Posted
July 25, 2012
Last Updated
August 6, 2012
Sponsor
Lievensberg Ziekenhuis
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1. Study Identification

Unique Protocol Identification Number
NCT01652105
Brief Title
Randomized Trial of Preoperative Diets Before Bariatric Surgery
Official Title
Comparison of Preoperative Diets Before Bariatric Surgery: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lievensberg Ziekenhuis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomized clinical trial of two preoperative diets before bariatric surgery (gastric bypass)comparing standard diet and Prodimed (VLCD) in 100 morbidly obese patients selected for a gastric bypass procedure
Detailed Description
Morbid obesity, defined as a body mass index (BMI) of > 40 kg/m² or > 35 kg/m² with obesity-related comorbidities, is a rapidly growing problem in the western society. In the United States, about 6 million people currently have a BMI of > 40 kg/m² and another 10 million people have a BMI of > 35 kg/m² with comorbidities. Worldwide, the incidence of morbid obesity has doubled and about 300 million people are now obese. In the Netherlands the prevalence is less disturbing but the incidence of morbid obesity is rising progressively to 1.5% of the total population. At this moment surgical therapy is the only treatment option for these patients that results in sufficient long-term weight loss. Non-surgical approaches, like low energy diets and behavior modification, are not successful in the long-term with respect to maintaining weight loss and decreasing obesity-related comorbidities. In order to increase weight loss and minimize complications a preoperative diet before bariatric has been advocated. However, the usual VLCD's are poorly tolerated by patients. In this study we aim to compare two preoperative diets in order to find the most suitable for this patient population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Bariatric Surgery, Gastric Bypass
Keywords
Gastric bypass, Preoperative diet, Prodimed

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diet
Arm Type
Experimental
Arm Description
New developed diet
Arm Title
Prodimed
Arm Type
Active Comparator
Arm Description
Standard VLCD
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard diet versus standard VLCD (Prodimed)
Primary Outcome Measure Information:
Title
Preoperative weight loss before bariatric surgery
Description
Weight loss in kg before operation
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
- operation time - blood loss - difficulty of procedure - short term complications - acceptance of diets according to patients
Description
Measured by VAS, diet books and questionnaires
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: morbid obesity according to IFSO criteria Exclusion Criteria: previous bariatric or gastric surgery severe psychiatric disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruben Schouten, Md, PhD
Email
schoutenruben@hotmail.com
Facility Information:
Facility Name
Bariatric Centre Lievensberg hospital
City
Bergen op Zoom
ZIP/Postal Code
4624 VT
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruben Schouten, Md, PhD
Email
schoutenruben@hotmail.com

12. IPD Sharing Statement

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Randomized Trial of Preoperative Diets Before Bariatric Surgery

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