The main aim of this project is to assess the safety and efficiency of the SASI Bipartition.
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.
Study Type
OBSERVATIONAL
Enrollment
280
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.
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.
Aleris Hospital
Oslo, Norway
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
Time frame: 3 to 60 months after surgery
Waist size change
Waist size (in cm)
Time frame: 3 to 60 months after surgery
Medical and surgical complication
According to Clavien-Dindo classification
Time frame: 3 to 60 months after surgery
Operative time
Expressed in minutes
Time frame: During surgery
Hemoglobin
Measurement of Hemoglobin will explore the nutritional status of patients. Results will be expressed in g/l
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: before surgery up to 60 months after surgery
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Parathyroid hormone (PTH)
Measurement of PTH will explore the nutritional status of patients. Results will be expressed in pmol/L
Time frame: 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
Time frame: 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
Time frame: before surgery up to 60 months after surgery
Fasting glycemia
Measurement of fasting glycemia will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
Time frame: before surgery up to 60 months after surgery
HbA1c
Measurement of HbA1c will explore the Metabolic efficiency of surgery. Results will be expressed in %
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 to 60 months after surgery