An interventional study of Dietary and nutritional recommendations conducted by a nurse in Dumping Syndrome, sponsored by University Hospital, Lille. Completed at 4 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-04-21.
Sponsored by University Hospital, Lille · Not applicable, Interventional, and Other
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.
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.
20 studies on the registry are indexed under Dumping Syndrome; 3 are open to participants now.
This study's enrollment of 135 is above the median of 30 across 17 interventional studies indexed under Dumping Syndrome.
Browse Dumping Syndrome studies →University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postoperative personalized approach based on dietary and nutritional recommendations conducted by a nurse
Behavioral: Dietary and nutritional recommendations conducted by a nurse
Postoperative standard of care
Supplementary dietary and nutritional education
The frequency of dumping syndrome
The frequency of dumping syndrome at 3 months will be compared between the two groups.
Time frame: 3 months
Change in Body Mass Index
Time frame: 3 months
Frequence of Adverse Events after surgery
Time frame: 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)
Time frame: 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)
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2017 to primary completion in Dec 2020, 45 months.
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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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