Non-randomized Prospective Comparison Between SASI Bipartition and RYGB

Study Overview
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Brief Summary
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The main aim of this project is to assess the safety and efficiency of the SASI Bipartition.

Detailed Description
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The Roux-en-Y Gastric Bypass (RYGB) is the procedure of choice in morbid obesity with metabolic disorders in most of the reference centers. Recent data describes the SASI Bipartition as being as efficient on weight loss and co-morbidities as the RYGB, with the advantage of being less technically difficult and less morbidity. In order to draw definite conclusions regarding the procedure, larger series with longer follow-up are necessary. Patients with BMI over 40, or with BMI over 35 with comorbidities are offered SASI Bipartition with 300 cm common limb or standard RYGB. Follow up is performed through visits at 3, 12, 24, 36, 48, and 60 months after surgery. Results on weight loss, comorbidities resolution, complications, and need of supplements are registered.

Official Title
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Long-term Outcomes of Bariatric Patients Treated With Gastric Bypass or Single-anastomosis Sleeve Ileal Bypass (SASI Bipartition)

Conditions
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Obesity, Morbid, Metabolic Syndrome, Bariatric Surgery Candidate, Postoperative Complications

Intervention / Treatment
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* Procedure: SASI Bipartition
* Procedure: Gastric bypass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Morbid obesity with BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with one or more co-morbidities (type 2 diabetes, arterial hypertension, sleep apnea, dyslipidemia, arthritis) Exclusion Criteria: Mental diseases Drug addiction Alcoholic Malignancy Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SASI Bipartition<br>Subjects submitted to SASI Bipartition | Procedure: SASI Bipartition<br>* SASI Bipartition is performed with a sleeve gastrectomy over a 32 French gastric bougie and a 300 cm common limb. Side-to-side gastroileostomy with a diameter of approximately 2.5 cm at the anterior part of antrum, 6 cm proximal to pylorus.<br>* Other names: Single-anastomosis Sleeve Ileal Bypass;|
| Roux-en-Y gastric bypass<br>Subjects submitted to gastric bypass | Procedure: Gastric bypass<br>* A small gastric pouch (15 mL) is created, and the jejunum brought up as an antecolic and antegastric fashion. Routine limb lengths were 150 cm for the alimentary limb and 60 cm for the bilio-pancreatic limb. Both mesenteric defects are closed with the Endohernia® stapler.<br>* Other names: Roux-en-Y gastric bypass;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change | Measured as percent of Excess Weight Loss (%EWL) using the following formula: ((weight at each study visit - initial weight) / (initial weight - ideal weight)) X 100 | 3 to 60 months after surgery | 
| Waist size change | Waist size (in cm) | 3 to 60 months after surgery | 
| Medical and surgical complication | According to Clavien-Dindo classification | 3 to 60 months after surgery | 
| Operative time | Expressed in minutes | During surgery | 
| Hemoglobin | Measurement of Hemoglobin will explore the nutritional status of patients. Results will be expressed in g/l | before surgery up to 60 months after surgery | 
| Albumin | Measurement of albumin will explore the nutritional status of patients. Results will be expressed in g/l | before surgery up to 60 months after surgery | 
| Ferritin | Measurement of ferritin will explore the nutritional status of patients. Results will be expressed in microg/l | before surgery up to 60 months after surgery | 
| Iron | Measurement of iron will explore the nutritional status of patients. Results will be expressed in micromol/l | before surgery up to 60 months after surgery | 
| Parathyroid hormone (PTH) | Measurement of PTH will explore the nutritional status of patients. Results will be expressed in pmol/L | before surgery up to 60 months after surgery | 
| Vitamin B12 | Measurement of vitamin B12 will explore the nutritional status of patients. Results will be expressed in pmol/l | before surgery up to 60 months after surgery | 
| Vitamin D | Measurement of vitamin D will explore the nutritional status of patients. Results will be expressed in nmol/l | before surgery up to 60 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glycemia | Measurement of fasting glycemia will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l | before surgery up to 60 months after surgery | 
| HbA1c | Measurement of HbA1c will explore the Metabolic efficiency of surgery. Results will be expressed in % | before surgery up to 60 months after surgery | 
| Triglycerides | Measurement of triglycerides will explore the Metabolic of surgery. Results will be expressed in mmol/l | before surgery up to 60 months after surgery | 
| Cholesterol | Measurement of cholesterol will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l | before surgery up to 60 months after surgery | 
| HDL | Measurement of HDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l | before surgery up to 60 months after surgery | 
| LDL | Measurement of LDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l | before surgery up to 60 months after surgery | 
| Antidiabetic drugs | Evolution of antidiabetic drugs will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment. | 3 to 60 months after surgery | 
| Antilipidemic drugs | Evolution of antilipidemic drugs will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment. | 3 to 60 months after surgery | 
| Antihypertensive drugs | Evolution of antihypertensive drugs will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment. | 3 to 60 months after surgery | 
| Use of Continuous Positive Airway Pressure for Obstructive Sleep Apnea (OSA) | Evolution of the use of Continuous Positive Airway Pressure will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of persistence or not of OSA. | 3 to 60 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric Bypass,, SASI Bipartition, Weight loss, GERD, Internal Hernia