Clinical Trials Directory

Trials / Completed

CompletedNCT02891330

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

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.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
135 (actual)
Sponsor
University Hospital, Lille · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALDietary and nutritional recommendations conducted by a nurseSupplementary dietary and nutritional education

Timeline

Start date
2017-03-02
Primary completion
2020-12-18
Completion
2020-12-18
First posted
2016-09-07
Last updated
2021-04-21

Locations

4 sites across 1 country: France

Source: ClinicalTrials.gov record NCT02891330. Inclusion in this directory is not an endorsement.