Bariatric Surgery Candidate, Metabolic Syndrome, Obesity, Morbid, Postoperative Complications
Conditions
Keywords
Gastric Bypass,, SASI Bipartition, Weight loss, GERD, Internal Hernia
Brief summary
The main aim of this project is to assess the safety and efficiency of the SASI Bipartition.
Detailed description
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.
Interventions
PROCEDURESASI Bipartition
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.
PROCEDUREGastric bypass
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.
Sponsors
Aleris Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D | before surgery up to 60 months after surgery | Measurement of vitamin D will explore the nutritional status of patients. Results will be expressed in nmol/l |
| Weight change | 3 to 60 months after surgery | 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 |
| Waist size change | 3 to 60 months after surgery | Waist size (in cm) |
| Medical and surgical complication | 3 to 60 months after surgery | According to Clavien-Dindo classification |
| Operative time | During surgery | Expressed in minutes |
| Hemoglobin | before surgery up to 60 months after surgery | Measurement of Hemoglobin will explore the nutritional status of patients. Results will be expressed in g/l |
| Albumin | before surgery up to 60 months after surgery | Measurement of albumin will explore the nutritional status of patients. Results will be expressed in g/l |
| Ferritin | before surgery up to 60 months after surgery | Measurement of ferritin will explore the nutritional status of patients. Results will be expressed in microg/l |
| Iron | before surgery up to 60 months after surgery | Measurement of iron will explore the nutritional status of patients. Results will be expressed in micromol/l |
| Parathyroid hormone (PTH) | before surgery up to 60 months after surgery | Measurement of PTH will explore the nutritional status of patients. Results will be expressed in pmol/L |
| Vitamin B12 | before surgery up to 60 months after surgery | Measurement of vitamin B12 will explore the nutritional status of patients. Results will be expressed in pmol/l |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | before surgery up to 60 months after surgery | Measurement of HbA1c will explore the Metabolic efficiency of surgery. Results will be expressed in % |
| Triglycerides | before surgery up to 60 months after surgery | Measurement of triglycerides will explore the Metabolic of surgery. Results will be expressed in mmol/l |
| Cholesterol | before surgery up to 60 months after surgery | Measurement of cholesterol will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l |
| HDL | before surgery up to 60 months after surgery | Measurement of HDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l |
| LDL | before surgery up to 60 months after surgery | Measurement of LDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l |
| Antidiabetic drugs | 3 to 60 months after surgery | 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. |
| Antilipidemic drugs | 3 to 60 months after surgery | 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. |
| Antihypertensive drugs | 3 to 60 months after surgery | 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. |
| Use of Continuous Positive Airway Pressure for Obstructive Sleep Apnea (OSA) | 3 to 60 months after surgery | 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. |
| Fasting glycemia | before surgery up to 60 months after surgery | Measurement of fasting glycemia will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l |
Countries
Norway
Outcome results
None listed