An Evaluation of the Outcomes of Bariatric Surgery - a Cohort Study

Study Overview
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Brief Summary
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A prospective bariatric database was carried out in the Department of Digestive and Endocrine Surgery at the University Hospital of Strasbourg, France, starting in January 1996. All potential candidates for obesity surgery were prospectively registered in the database. Patients were informed by the bariatric surgeon of the prospective database, and of the possibility of utilizing personal data for research purpose after anonymization. A case-control study was performed, to compare the quality of life (QoL) of patients treated for internal hernia (IH group) with the QoL of patients with an uncomplicated course after Roux en Y gastric bypass (Uncomplicated RYGB group).

Detailed Description
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A prospective bariatric database was carried out in the Department of Digestive and Endocrine Surgery at the University Hospital of Strasbourg, France, starting in January 1996. All potential candidates for obesity surgery were prospectively registered in the database. Patients were informed by the bariatric surgeon of the prospective database, and of the possibility of utilizing personal data for research purpose after anonymization. Patients were evaluated by a multidisciplinary team. The standard preoperative assessment included nutritional counseling, psychological evaluation, abdominal ultrasound, upper gastrointestinal endoscopy, and blood tests. Type and date of surgery, biological and clinical follow-up data and morbidity data were recorded prospectively in the database. A case-control study was performed, to compare the quality of life (QoL) of patients treated for internal hernia (IH group) with the QoL of patients with an uncomplicated course after Roux en Y gastric bypass (Uncomplicated RYGB group). Patients who had IH were paired with patients of the same age and sex and at the same postoperative interval. Paired patients were contacted by phone to obtain the QoL questionnaires, abdominal pain evaluation, and weight loss data.

Official Title
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An Evaluation of the Outcomes of Bariatric Surgery - a Cohort Study Internal Hernia After Laparoscopic Roux-en-Y Gastric Bypass: an Evaluation of the Impact on the Postoperative Course and a Quality of Life Case-control Study

Conditions
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Morbid Obesity

Intervention / Treatment
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* Procedure: Roux en Y gastric bypass
* Procedure: Sleeve gastrectomy
* Procedure: Gastric banding
* Procedure: Intragastric balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient >18 years old BMI > 35 kg/m² Exclusion Criteria: Incapacity of giving an informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Roux en Y gastric bypass|Laparoscopic RYGB is performed as following: a gastric pouch of approximately 30mL was obtained using successive firings of the Endo GIATM linear stapler, followed by the creation of an antecolic alimentary limb of 150cm and of a biliopancreatic limb of 75cm. A gastrojejunal anastomosis was fashioned with the PCEEA™ 28 circular stapler until 2012, and using the Endo GIA™ linear stapler afterwards. The mesenteric defect and Petersen's defect were closed using a non-absorbable running suture.|
|Procedure: Sleeve gastrectomy|Laparoscopic SG is performed as following: after greater curvature mobilization, the gastric tube was calibrated over a 36F bougie and transection started approximately 5-6 cm from the pylorus toward the left diaphragmatic crus, using successive firings of 3.5- or 4.8-mm-high staples, depending on gastric thickness.|
|Procedure: Gastric banding|Laparoscopic gastric banding is performed as following: a perigastric tunel is performed by blunt dissection and the banding is calibrated over the stomach.|
|Procedure: Intragastric balloon|Flexible endoscopy is used to place intragastric balloon for a maximum interval of six months.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excess weight loss |  | 1 - 3 - 5 - 10 - 15 and 30 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI |  | 1 - 3 - 5 - 10 - 15 and 30 years | 
| Albumin | Albumin | 1 - 3 - 5 - 10 - 15 and 30 years | 
| Pre-albumin | Pre-albumin | 1 - 3 - 5 - 10 - 15 and 30 years | 
| Vitamin A | Vitamin A | 1 - 3 - 5 - 10 - 15 and 30 years | 
| Vitamin D | Vitamin D | 1 - 3 - 5 - 10 - 15 and 30 years | 
| Vitamin B6 | Vitamin B6 | 1 - 3 - 5 - 10 - 15 and 30 years | 
| Vitamin B9 | Vitamin B9 | 1 - 3 - 5 - 10 - 15 and 30 years | 
| Vitamin B12 | Vitamin B12 | 1 - 3 - 5 - 10 - 15 and 30 years | 
| Plasma ferritin | Plasma ferritin | 1 - 3 - 5 - 10 - 15 and 30 years | 
| Fasting plasma glucose | Fasting plasma glucose | 1 - 3 - 5 - 10 - 15 and 30 years | 
| Serum insulin | Serum insulin | 1 - 3 - 5 - 10 - 15 and 30 years | 
| HbA1c | HbA1c | 1 - 3 - 5 - 10 - 15 and 30 years | 
| Triglycerides | Triglycerides | 1 - 3 - 5 - 10 - 15 and 30 years | 
| Cholesterol | Cholesterol (total, HDL, LDL) | 1 - 3 - 5 - 10 - 15 and 30 years | 
| Quality of life assessed by Moorehead-Ardelt Quality of life II questionnaire | Moorehead-Ardelt Quality of life II questionnaire | 1 - 3 - 5 - 10 - 15 and 30 years | 
| Quality of life assessed by Gastro-intestinal Quality of Life Index | Gastro-intestinal Quality of Life Index | 1 - 3 - 5 - 10 - 15 and 30 years | 
| Postoperative morbidity | Postoperative morbidity | 1 - 3 - 5 - 10 - 15 and 30 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity surgery, Roux en Y gastric bypass, sleeve gastrectomy, excess weight loss, quality of life