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

University Hospital, Lille

Status: Completed

Conditions: Dumping Syndrome

Treatments: Behavioral: Dietary and nutritional recommendations conducted by a nurse

Study type: Interventional

Funder types: Other

Identifiers

NCT02891330

2014_17

2015-A00646-43 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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135 participants in 2 patient groups

Dietary and nutritional recommendations

Experimental group

Description:

Postoperative personalized approach based on dietary and nutritional recommendations conducted by a nurse

Treatment:

Behavioral: Dietary and nutritional recommendations conducted by a nurse

Standard of care

No Intervention group

Description:

Postoperative standard of care