Hand-Sewn vs. Stapled Anastomosis in SADI-S: A Prospective Randomized Trial of Early Postoperative Complications.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Intestinal Injury
研究概览
简要总结
This study aims to compare the stapled and handsewn techniques of duodeno-ileal anastomosis in SADI-S regarding short-term outcomes in the form of anastomotic leak rate and anastomotic stricture rate, operative time, post-operative hospital stay, and complication rate (Clavien-Dindo≥ II).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-70
- •Patients who will undergo SADI-S surgery
排除标准
- •Patients with severe medical conditions such as heart failure and interstitial lung disease.
- •Patients with short bowel
- •Patients with severe GERD
- •Patients with cognitive and intellectual impairment with poor compliance to treatment and dietary supplements
- •Difficulty in intraoperative bowel measurement, i.e., extensive adhesions.
研究组 & 干预措施
Hand-sewn Single Anastomosis Duodeno-Ileal Sleeve (SADI-S)
干预措施: Hand-sewn Single Anastomosis Duodeno-Ileal Sleeve (SADI-S) (Procedure)
Stapled Single Anastomosis Duodeno-Ileal Sleeve (SADI-S)
干预措施: Stapled Single Anastomosis Duodena-ileal Sleeve (Procedure)
结局指标
主要结局
Intestinal Injury
时间窗: One month after surgery
Anastomotic Leak Rate
时间窗: one month after the surgery
Post operative Bleeding
时间窗: One month after surgery
Anastomotic Stircture
时间窗: Six months after surgery
Operative Time
时间窗: Immediately after surgery
次要结局
- Weight loss(Six months after surgery)
- Length of Hosptial Stay(One month after surgery)
研究者
Ahmed Abdelsalam M
Associate Professor of General and Laparoscopic Surgery
Kasr El Aini Hospital