NCT05948852尚未招募不适用
Randomized Prospective Study Comparing Two Hypoabsorption Techniques for the Treatment of Type III Obesity (Body Mass Index Between 45 - 49.9 Kg/m2): Single Anastomose Duodenal Switch (SADI-S) and Single Anastomose Gastric By-pass (OAGBP)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 96
- 主要终点
- the percentage of total weight loss (%TWL) of the patients after surgery
研究概览
简要总结
This study aims to compare the percentage of total weight lost in long-term follow-up after two surgical interventions (SADIS and OAGB) in patients with morbid obesity BMI between 45-49.9.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 and under 65 who meet criteria for bariatric surgery.
- •Maximum BMI between 45 and 50 kg/m2 and indication for surgery in a time
- •Signature of the informed consent of the study
- •Patients suitable for laparoscopic surgery
排除标准
- •Previous bariatric surgery
- •2-stage surgery
- •Contraindication for hypoabsorptive surgery due to previous pathology: inflammatory bowel disease, transplant recipient or transplant candidate, previous intestinal resection surgery
- •Other associated surgical procedures in the same intervention.
- •Conversion to laparotomy
研究组 & 干预措施
Group A: SADI-S
Experimental
SINGLE ANASTOMOSE DUODENAL SWITCH
干预措施: metabolic surgery (SADIS and OAGB) (Procedure)
Group B: OAGB
Active Comparator
SINGLE ANASTOMOSE GASTRIC BY-PASS
干预措施: metabolic surgery (SADIS and OAGB) (Procedure)
结局指标
主要结局
the percentage of total weight loss (%TWL) of the patients after surgery
时间窗: Baseline, 1 year, 3 year, 5 year after SADI-S and OAGBP surgery
次要结局
- % of patients with gastroesophageal reflux (acid and bile) after surgery(1 year, 3 year, 5 year after SADI-S and OAGBP surgery)
- Number of Participants with complications in the immediate postoperative period(up to day 90 post-intervention)
- Number of patients with nutritional deficiencies(1 year, 3 years, 5 years after SADI-S and OAGBP surgery)
- Number of deaths in the immediate postoperative period(up to day 90 post-intervention)
- Ratio of patients with more than 3 loose stools per day(1 year, 3 years, 5 years after the surgery)
- questionnaire of quality of life(1 year, 3 years, 5 years after SADI-S and OAGBP surgery)
研究者
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