Impact of an Educational Personalized Clinical Support Device Preventive and a Referent Nurse in Surgery for Obesity

Study Overview
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Brief Summary
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The postprandial dumping syndrome is a frequent consequence of Roux-en-Y Gastric ByPass due to the rapid emptying of the stomach remnant in to the intestinal lumen. Dumping-related symptoms occur very early after eating (within 30 minutes), are not associated with concurrent hypoglycemia, and are most prominent in the early postoperative period. This syndrome very debilitating for the patient can be improved by dietary and nutritional recommendations. We hypothesize that a personalized approach based on dietary and nutritional recommendations conducted by a nurse would likely to decrease the frequency of dumping syndrome and improve the postoperative quality of life of patients in the early postoperative period.

Detailed Description
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The Roux-en-Y Gastric ByPass is considered the gold standard of weight loss surgery and is the most commonly performed bariatric procedure worldwide.The postprandial dumping syndrome is a frequent consequence of gastrojejunal anastomosis due to the rapid emptying of the stomach remnant in to the intestinal lumen. Dumping-related symptoms occur very early after eating (within 30 minutes), are not associated with concurrent hypoglycemia, and are most prominent in the early postoperative period. The symptoms of dumping syndrome include nausea, abdominal cramps, diarrhea, dizzy spells, weakness and cold sweats either with or after eating.This syndrome very debilitating for the patient can be improved by dietary and nutritional recommendations. We hypothesize that an individualized approach based on dietary and nutritional recommendations and monitoring of patients conducted by a nurse in the first three months after surgery would likely to decrease these problems and improve the postoperative quality of life of patients.

Official Title
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Assessing the Impact of an Educational Personalized Clinical Support Device Preventive and a Referent Nurse in Surgery for Obesity With the Risk of Occurrence of Dumping Syndrome After Gastric Bypass.

Conditions
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Dumping Syndrome

Intervention / Treatment
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* Behavioral: Dietary and nutritional recommendations conducted by a nurse


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index ≥40 kg / m2 or ≥35 kg / m2 in the presence of comorbidities related to obesity Indication to Roux-en-Y Gastric ByPass Exclusion Criteria: Contraindication to Roux-en-Y Gastric ByPass Refusal to sign the consent form Patient not affiliated to a social security system Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary and nutritional recommendations<br>Postoperative personalized approach based on dietary and nutritional recommendations conducted by a nurse | Behavioral: Dietary and nutritional recommendations conducted by a nurse<br>* Supplementary dietary and nutritional education<br>|
| No Intervention: Standard of care<br>Postoperative standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of dumping syndrome | The frequency of dumping syndrome at 3 months will be compared between the two groups. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Mass Index |  | 3 months | 
| Frequence of Adverse Events after surgery |  | at 1 and 3 months | 
| Quality of Life-Lite questionnaire | Estimation of quality of life by Impact of Weight on Quality of Life-Lite questionnaire(IWQOL-Lite) | 3 months | 
| Personal Effectiveness Assessment questionnaire (SEPOB) | Measure the efficacy of therapeutic education by personal estimation of the level of skill using a specific obesity assessment questionnaire (SEPOB questionnaire or survey emotional, cognitive and behavioral sense of personal efficacy) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Roux-en-Y Gastric ByPass