NCT06298942Unknown不适用
Naturally Banded Versus Synthetic Banding of Sleeve Gastrectomy
Minia University0 个研究点目标入组 250 人开始时间: 2024年3月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 主要终点
- total cost
研究概览
简要总结
to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver)
详细描述
to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver) as regard weight loss, complications rat and cost
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
- None
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
- •obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
- •patients fit for laparoscopic surgery
- •give approval to share in the study
排除标准
- •patients refused to share in the study
- •patients unfit for surgery
- •patients aged less than 18 and older than 65
- •patient with previous upper abdominal surgery either for obesity or other diseases
- •revisional bariatric procedures
研究组 & 干预措施
natural band
Experimental
to use an round ligament as a natural band in stead of synesthetic band with sleeve gastrectomy
干预措施: natural band (Procedure)
silicone band
Active Comparator
to use a synesthetic band with sleeve gastrectomy
干预措施: silicone band (Procedure)
结局指标
主要结局
total cost
时间窗: 12 hours
total operative cost in Egyptian pound (LE)
food intolerance
时间窗: 1 year
food intolerance at one year food tolerance arabic score questionnaire
次要结局
- %EWL(1 year)
- improvement of comorbidities(1 year)
- complications rate(1 year)
研究者
Alaa Mstafa Hassan Sewefy
professor & consultant of general surgery,
Minia University
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