NCT05603338已完成不适用
Naturally Banded Sleeve Gastrectomy
Minia University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- the effect on weight loss
研究概览
简要总结
the idea is to use an omental flap or round ligament as a natural band in stead of synesthetic band in bariatric procedures, mainly gastric sleeve
详细描述
the idea is to use an omental flap or round ligament as a natural band in stead of synesthetic band in bariatric procedures, mainly gastric sleeve
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（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
- •previous restrictive bariatric procedure
排除标准
- •patients unfit for surgery
- •patients aged less than 18 and older than 60
- •patient with previous upper abdominal surgery either for obesity or other diseases
结局指标
主要结局
the effect on weight loss
时间窗: 12 months
the effect on weight loss determined by percentage of excess weight loss, percentage of total weight loss and change of BMI
the size of gastric pouch at one year
时间窗: 12 months
the size of gastric pouch after sleeve gastrectomy in cc at one year using gastric volumetric study
次要结局
- operative time(6 hours)
- the effect on comorbidities(12 monthts)
- the incidences of complications(12 monthss)
研究者
Alaa Mstafa Hassan Sewefy
assistant professor of general surgery
Minia University
研究点 (2)
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