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

Not Applicable

Completed

• Conditions: Dumping Syndrome
• Interventions: Behavioral: Dietary and nutritional recommendations conducted by a nurse

• Registration Number: NCT02891330
• Lead Sponsor: University Hospital, Lille

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-09-01
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-07
• Study Start: 2017-03-02
• Primary Completion: 2020-12-18
• Study Completion: 2020-12-18
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-20
• Last Update Posted: 2021-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

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Exclusion Criteria

• Contraindication to Roux-en-Y Gastric ByPass
• Refusal to sign the consent form
• Patient not affiliated to a social security system
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary and nutritional recommendations	Dietary and nutritional recommendations conducted by a nurse	Postoperative personalized approach based on dietary and nutritional recommendations conducted by a nurse

Primary Outcome Measures

Name	Time	Method
The frequency of dumping syndrome	3 months	The frequency of dumping syndrome at 3 months will be compared between the two groups.

Secondary Outcome Measures

Name	Time	Method
Personal Effectiveness Assessment questionnaire (SEPOB)	3 months	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)
Change in Body Mass Index	3 months
Frequence of Adverse Events after surgery	at 1 and 3 months
Quality of Life-Lite questionnaire	3 months	Estimation of quality of life by Impact of Weight on Quality of Life-Lite questionnaire(IWQOL-Lite)

Trial Locations

Locations (4)

CH ARRAS; 🇫🇷 Arras, France

Ch Boulogne-Sur-Mer; 🇫🇷 Boulogne Sur Mer, France

Hôpital Claude Huriez, CHRU; 🇫🇷 Lille, France

Ch de Valenciennes; 🇫🇷 Valenciennes, France