Long-term Outcomes of Bariatric Patients Treated With Gastric Bypass or Single-anastomosis Sleeve Ileal Bypass (SASI Bipartition)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Operative time
研究概览
简要总结
The main aim of this project is to assess the safety and efficiency of the SASI Bipartition.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Mental diseases
- •Drug addiction
- •Alcoholic
- •Malignancy
- •Pregnancy
结局指标
主要结局
Operative time
时间窗: During surgery
Expressed in minutes
Vitamin B12
时间窗: 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
时间窗: 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
Hemoglobin
时间窗: 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
Weight change
时间窗: 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
时间窗: 3 to 60 months after surgery
Waist size (in cm)
Medical and surgical complication
时间窗: 3 to 60 months after surgery
According to Clavien-Dindo classification
Albumin
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- Cholesterol(before surgery up to 60 months after surgery)
- LDL(before surgery up to 60 months after surgery)
- HDL(before surgery up to 60 months after surgery)
- Antidiabetic drugs(3 to 60 months after surgery)
- HbA1c(before surgery up to 60 months after surgery)
- Antilipidemic drugs(3 to 60 months after surgery)
- Antihypertensive drugs(3 to 60 months after surgery)
- Use of Continuous Positive Airway Pressure for Obstructive Sleep Apnea (OSA)(3 to 60 months after surgery)
- Triglycerides(before surgery up to 60 months after surgery)
- Fasting glycemia(before surgery up to 60 months after surgery)
研究者
Ebrahim Aghajani
Gastrointestinal Surgeon, PhD, Principal investigator
Aleris Hospital