Non-randomized Prospective Comparison Between SASI Bipartition and RYGB
- Conditions
- Postoperative ComplicationsObesity, MorbidMetabolic SyndromeBariatric Surgery Candidate
- Interventions
- Procedure: SASI BipartitionProcedure: Gastric bypass
- Registration Number
- NCT04469712
- Lead Sponsor
- Aleris Hospital
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 280
- 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)
- Mental diseases
- Drug addiction
- Alcoholic
- Malignancy
- Pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SASI Bipartition SASI Bipartition Subjects submitted to SASI Bipartition Roux-en-Y gastric bypass Gastric bypass Subjects submitted to gastric bypass
- Primary Outcome Measures
Name Time Method 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
Operative time During surgery Expressed in minutes
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
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
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 100Waist 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
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
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
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
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
- Secondary Outcome Measures
Name Time Method 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
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
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.
HbA1c before surgery up to 60 months after surgery Measurement of HbA1c will explore the Metabolic efficiency of surgery. Results will be expressed in %
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
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
Trial Locations
- Locations (1)
Aleris Hospital
🇳🇴Oslo, Norway