Laparoscopic Single-Anastomosis Duodenal-Jejunal Bypass With Sleeve Gastrectomy vs Laparoscopic Duodenal Switch as a Primary Bariatric Procedure. 5 Year Patient Follow
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 主要终点
- Excess weight loss
研究概览
简要总结
Will a laparoscopic Single-Anastomosis Duodenal-ileal Bypass with Sleeve Gastrectomy produce similar or superior results when compared to a laparoscopic Duodenal Switch, as a primary surgical procedure for weight loss in bariatric patients over a 5 year period?
详细描述
The aims of this study are: (a) to compare SADI vs DS as a primary bariatric procedure for weight loss; (b) to compare the minor and major complications of SADI vs DS (c) to compare SADI vs DS for remission rates of type 2 diabetes (d) to compare SADI vs DS for remission rates of hypertension (e) to compare SADI vs DS for weight regain at 5 years (f) to compare SADI vs DS for metabolic alterations. The investigators hypothesize that both procedures will have similar weight loss and metabolic remission results. If the complication rates of SADI are similar or superior to the complication rates of the DS, then the investigators could propose the SADI as a viable alternative to the DS in patients with high BMIs requiring increased weight loss.
The investigators will conduct a prospective randomized study. The study will include 140 patients who are scheduled for bariatric procedures. The patients will be stratified into 2 groups. The first group will continue according to the standard bariatric preoperative protocol and will be assigned to a DS. The second group will also follow standard bariatric preoperative protocol but will be assigned to a SADI. Follow up of all patients will continue according to the usual bariatric clinic guidelines.
From literature, the mean excess body weight loss is 77.65% with standard deviation of 21% for Duodenal Switch bariatric surgery. If there is in truth no difference between the Duodenal Switch and SADI for excess body weight loss, then 140 patients (70 per group) are required to have 80% power for the lower limit of a one-sided 97.5% confidence interval (or equivalently a 95% two-sided confidence interval) will be above the non-inferiority limit of -10%.
Participants must meet ALL of the following inclusion criteria:
- Fulfilled criteria for bariatric surgery as coined by National Institutes of Health.
- Their age is ≥18 years and ≤70 years
- Able and willing to give written consent
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
- •Participants must meet ALL of the following inclusion criteria:
- •Fulfilled criteria for bariatric surgery as coined by National Institutes of Health.
- •Their age is ≥18 years and ≤70 years
- •Able and willing to give written consent
排除标准
- •Participants who meet any of the following criteria at the time of the baseline visit are NOT eligible to be enrolled in this study:
- •Contra-indication to general anesthesia
- •Any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
- •Pregnant or lactating female (Women of child bearing potential must take a pregnancy test prior to surgery)
- •History of alcohol abuse (>30 g/day in men or >20 g/day in women)
结局指标
主要结局
Excess weight loss
时间窗: 5 years
BMI and body weight will be measured and compared to preoperative reference values
次要结局
- Remission of hypertension(5 years)
- Surgical complications(1 year)
- Metabolic alterations(5 years)
- Remission of type 2 diabetes(5 years)
研究者
Dennis Hong MD
Principal Investigator, General Surgeon
McMaster University