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Obesity is a major public health problem and is constantly on the rise. Therapeutic approaches based on dietary advice, physical activity and the management of psychological difficulties are not always sufficient to achieve a lasting weight reduction.
Bariatric surgery (or obesity surgery), accompanied by therapeutic education and adequate medical and dietary monitoring, can lead to significant and lasting weight loss. It is indicated as a second-line treatment for patients who have failed medical treatment, whose BMI is greater than or equal to 40 or whose BMI is greater than or equal to 35 with comorbidities (type 2 diabetes, arterial hypertension, obstructive sleep apnoea-hypopnoea syndrome, severe joint disorders).
The surgeon may be very bothered by the intra-abdominal fat mass and especially by steatotic hepatomegaly (increase in the size of the liver and its fat load).
Faced with this problem, various preoperative strategies such as the placement of an intra gastric balloon have been tried to decrease the size of the liver but a systematic review from 2016 indicates that a low calorie diet is preferable. Preoperative weight loss can reduce fat load and liver volume very rapidly. This meta-analysis shows that all low-calorie, high-protein diets are effective and that the optimal duration (4 weeks), compliance and tolerance are important factors for success.
Obesity is a major public health problem and is constantly on the rise. Therapeutic approaches based on dietary advice, physical activity and the management of psychological difficulties are not always sufficient to achieve a lasting weight reduction.
Bariatric surgery (or obesity surgery), accompanied by therapeutic education and adequate medical and dietary monitoring, can lead to significant and lasting weight loss. It is indicated as a second-line treatment for patients who have failed medical treatment, whose BMI is greater than or equal to 40 or whose BMI is greater than or equal to 35 with comorbidities (type 2 diabetes, arterial hypertension, obstructive sleep apnoea-hypopnoea syndrome, severe joint disorders).
The surgeon may be very bothered by the intra-abdominal fat mass and especially by steatotic hepatomegaly (increase in the size of the liver and its fat load).
Faced with this problem, various preoperative strategies such as the placement of an intra gastric balloon have been tried to decrease the size of the liver but a systematic review from 2016 indicates that a low calorie diet is preferable. Preoperative weight loss can reduce fat load and liver volume very rapidly. This meta-analysis shows that all low-calorie, high-protein diets are effective and that the optimal duration (4 weeks), compliance and tolerance are important factors for success.
However, there is no consensus on the benefit/risk balance of a preoperative diet and there is considerable variability in approach at national and international level.
The present clinical study involves a triad of dietician, surgeon, physician (endocrinologist/nutritionist or internist) to secure this diet. It could provide a database to help estimate the risk of undernutrition in the obese subject.
This diet, designed to facilitate the surgical procedure and potentially reduce intraoperative complications, is inexpensive, easily accessible and reproducible by other teams. This innovative management could standardise the preoperative management of patients undergoing bariatric surgery at national level. It would also improve the results of bariatric surgery both in the short term by reducing complications and in the long term by increasing weight reduction as reported in the Livhits meta-analysis. The risk of undernutrition should be reduced by this hypocaloric hyperprotein diet and consequently cancel out the increased risk of mortality, infections, delayed healing, longer hospital stay and the costs that this would entail.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With diet | Experimental | A low-calorie, high-protein diet will be prescribed to the patient for a period of 4 weeks. The diet will be done the 4 weeks before the bariatric surgery |
|
| Without diet | Other | A low-calorie, high-protein diet will not be prescribed to the patient for a period of 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| With low-calorie, high-protein diet | Dietary Supplement | A low-calorie, high-protein diet will be prescribed to the patient for a period of 4 weeks. The diet will be done the 4 weeks before the bariatric surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Poor diet tolerance | At least one of the following biological abnormalities at the end of the diet period:
OR At least one of the following clinical abnormalities:
| 4 weeks after the beggining of the diet |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | Weight difference between Visit 3 and Visit 2 | 4 weeks after the beggining of the diet and 3 months postoperatively |
| Reduced muscle strength | Difference in muscle strength measured with a HandGrip at Visit 2 and Visit 3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christèle DAVID | Contact | +33232888624 | christele.david@chu-rouen.fr | |
| Déborah LEBEDIEFF | Contact | +33232888265 | deborah.lebedieff@chu-rouen.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ch Dieppe | Recruiting | Dieppe | France |
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| ID | Term |
|---|---|
| D056128 | Obesity, Abdominal |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000073600 | Diet, High-Protein |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Without low-calorie, high-protein diet | Dietary Supplement | A low-calorie, high-protein diet will not be prescribed to the patient for a period of 4 weeks. |
|
| 4 weeks after the beggining of the diet |
| Comparison of the quality of life between "with diet" and "without diet" with "EQVOD" questionnaire | Evaluated using the EQVOD questionnaire at baseline (V2), end of diet (V3) and 3 months postoperatively Score from 36 to 180 | Baseline, 4 weeks after the beggining of the diet and 3 months postoperatively |
| Evolution of physical activity | Physical activity evaluated using the Ricci et Gagnon questionnaire at baseline (V2), end of diet (V3) and 3 months postoperatively | Baseline, 4 weeks after the beggining of the diet and 3 months postoperatively |
| Digestive tolerance | Digestive tolerance evaluated using auto-questionnaire about nausea, vomiting, diarrhoea, constipation forthe interventional group, in the month of the diet | during the 4 weeks of the diet |
| Compliance | Evaluated by a food diary and the full bottles (not consumed) brought back for the intervention group, in the month of the diet | during the 4 weeks of the diet |
| Degree of exposure | Assessment of the degree of exposure of the oesogastric junction and hepatomegaly on a subjective scale of 1 to 5 by the surgeon | one day from surgery |
| Operating time | Number of hours and minuts about surgery | one day from surgery |
| Length of hospital stay | Number of days in hospital for the surgery | Four months from surgery |
| Intraoperative and postoperative complications | Delayed healing, infection and cancellation of surgery or conversion to laparotomy) up to 3 months post-operatively | Between surgery and 3 months postoperatively |
| HPE | Recruiting | Le Havre | France |
|
| CHU de ROUEN | Recruiting | Rouen | 76 000 | France |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |