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The aim of this study is to assess that the sleeve gastrectomy can improve the risk benefit than the gastric bypass
In the obese patient population, the frequency of patients presenting a severe morbid obesity (40 >= BMI <= 50), a super obesity (BMI >50), a super super obesity (BMI>60), and obese patients (BMI>35) with a failure of gastric banding is constantly increasing. In these patients, the surgery risk is proportionate to the weight and / or gastric surgery records.
This risk is high, in bariatric surgery, for gastric bypass procedure. This justifies the evaluation of new procedure to reduce the morbidity allowing the reduction of morbid /mortality associated with the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Sleeve gastrectomy |
|
| 2 | Active Comparator | Gastric Bypass |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleeve gastrectomy | Procedure | Laparoscopic sleeve gastrectomy is a restrictive procedure for the treatment for morbid obesity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite criteria of morbid/mortality | during 18 months and 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of morbid events | during the follow up | |
| Percentage of excess weight loss | during 18 and 36 months | |
| Frequency of patients having a excess weight loss superior than 50% |
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Inclusion Criteria:
Patient aged from 18 to 60 years old
Patient having given his consent to the use of data from the project
Patient fulfilling the inclusion criteria for surgery of obesity according to the ANAES (french national health service)
Patient presenting one of the following criteria:
Preliminary agreement during the consultation of a psychiatrist / psychologist
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Marc CATHELINE, MD, PhD | Assistance Publique - Hôpitaux de Paris / Hôpital De la Fontaine (St Denis) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de chirurgie digestive / Centre Hospitalier Général de Saint-Denis Delafontaine | Saint-Denis | 93205 | France |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015390 | Gastric Bypass |
| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
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| Gastric Bypass | Procedure | Laparoscopic gastric bypass is a restrictive and difficult absorption procedure for the treatment of morbid obesity |
|
|
| during 36 months |
| Regression of morbidities | during 36 months |
| Rate serum ghrelin | at inclusion visit, 6, 12, 18 and 36 months |
| Evaluation of quality of life and scores of precariousness, SF 36, EPWORTH Score, Lequesne' Score, Insecure' Score | at inclusion visit, 6, 12, 18 and 36 months |
| Frequency of morbid/mortality events | during 36 months |
| Frequency of patients having excess weight loss superior than 50% | during 18 month |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005763 |
| Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |