Comparison of Staple Line Suturing Reinforcement Methods in Laparoscopic Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Immediate and early post-operative complication
研究概览
简要总结
Sleeve gastrectomy (SG) involves the creation of small gastric reservoir based on lesser curvature of the stomach, which is fashioned by a longitudinal gastrectomy that preserves the antrum and pylorus together with its vagal innervation. Recently SG is viewed as a multi-purpose bariatric procedure that restricts the stomach size to induce satiety and resects fundal ghrelin-producing cells to decrease appetite. However, the risk of staple line leak and bleeding remains one of its challenging complications. Despite the fact that there are a large number of studies assessing various methods of making the staple line secure, there is to date, no consensus on which technique is best for reducing the risk of stapler line bleeding and leak. Hence, this study aims to compare staple line suturing reinforcement methods in sleeve gastrectomy using plication and over-sewing techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
This is a single blinded randomisation whereby the patient is not aware on the staple-line suturing reinforcement used. Suturing reinforcement of the staple-line is our standard of care in all laparoscopic sleeve gastrectomy patients
入排标准
- 年龄范围
- 18 Years 至 64 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at our Bariatric Clinic fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic sleeve gastrectomy as primary bariatric procedure will be evaluated for possible inclusion
排除标准
- •Age < 18 or > 65
- •BMI < 35 and > 60 kg/m2
- •American Society of Anesthesiologists (ASA) score > 3
- •Concurrent surgical procedure including:
- •ventral hernia repair
- •cholecystectomy
- •hiatal hernia repair with posterior cruroplasty
- •extensive lysis of adhesions
- •other procedures that mandate addition of 'trocar(s)' or 'feeding tube'
结局指标
主要结局
Immediate and early post-operative complication
时间窗: 0-30 days
Staple line bleeding
次要结局
- Immediate and early post-operative complication(0-30 days)
研究者
Zubaidah Nor hanipah
Associate Professor Dr
Universiti Putra Malaysia
