Clinical trial NCT02891330: Impact of an Educational Personalized Clinical Support Device Preventive and a Referent Nurse in Surgery for Obesity
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dumping Syndrome
Keywords: Roux-en-Y Gastric ByPass
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: The frequency of dumping syndrome
timeFrame: 3 months
Secondary outcomes:
measure: Change in Body Mass Index
timeFrame: 3 months
measure: Frequence of Adverse Events after surgery
timeFrame: at 1 and 3 months
measure: Quality of Life-Lite questionnaire
timeFrame: 3 months
measure: Personal Effectiveness Assessment questionnaire (SEPOB)
timeFrame: 3 months
Other outcomes:
Locations:
city: Arras
country: France
facility: CH ARRAS
city: Boulogne Sur Mer
country: France
facility: Ch Boulogne-Sur-Mer
city: Lille
country: France
facility: Hôpital Claude Huriez, CHRU
city: Valenciennes
country: France
facility: Ch de Valenciennes
Study officials:
affiliation: University Hospital, Lille
name: Hélène VERKINDT, MD
role: PRINCIPAL_INVESTIGATOR
References: