A Comparative Study of Staple Line Reinforcement Techniques in Laparoscopic Sleeve Gastrectomy : Omentopexy With Plication Versus Titanium Clips
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- incidence of postoperative leakage
研究概览
简要总结
This prospective comparative cohort study was conducted in accordance with the Declaration of Helsinki and approved by the Ethical Committee of the Medical Research Institute. All consecutive patients undergoing laparoscopic sleeve gastrectomy (LSG) between January 2022 and June 2024 in Baghdad were screened for eligibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •BMI more than or equal to 40
- •BMI equal or more than 35 with comorbidities
排除标准
- •history of previous bariatric procedure
研究组 & 干预措施
group B : Titanium clips
staple line reinforcement and homeostasis by using titanium clips
干预措施: titanium clips (Other)
group A: omentopexy
complete staple line invagination using continuous seromuscular suturing with omentopexy
干预措施: laprascopic sleeve gastrectomy with omentopexy and suturing (Other)
结局指标
主要结局
incidence of postoperative leakage
时间窗: up to 6 weeks postoperatively
presence of clinical signs (fever , tachycardia ) or radiological evidence of contrast extravasation
次要结局
未报告次要终点
研究者
Safaa Hadi Abdulsattar Alshihmani
M.B.Ch.B - F.I.B.M.S ,specialist in general and laprascopic surgey
Al-Kindy Teaching Hospital