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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00646-43 | Other Identifier | ID-RCB number, ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary and nutritional recommendations | Experimental | Postoperative personalized approach based on dietary and nutritional recommendations conducted by a nurse |
|
| Standard of care | No Intervention | Postoperative standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary and nutritional recommendations conducted by a nurse | Behavioral | Supplementary dietary and nutritional education |
|
| Measure | Description | Time Frame |
|---|---|---|
| The frequency of dumping syndrome | The frequency of dumping syndrome at 3 months will be compared between the two groups. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass Index | 3 months | |
| Frequence of Adverse Events after surgery | at 1 and 3 months | |
| Quality of Life-Lite questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hélène VERKINDT, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH ARRAS | Arras | France | ||||
| Ch Boulogne-Sur-Mer |
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Estimation of quality of life by Impact of Weight on Quality of Life-Lite questionnaire(IWQOL-Lite) |
| 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) | 3 months |
| Boulogne-sur-Mer |
| 62321 |
| France |
| Hôpital Claude Huriez, CHRU | Lille | France |
| Ch de Valenciennes | Valenciennes | France |
| ID | Term |
|---|---|
| D004377 | Dumping Syndrome |
| ID | Term |
|---|---|
| D011178 | Postgastrectomy Syndromes |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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