Impact of ePTFE Suture for Pancreaticojejunosotmy on Clinically Relevant Post-operative Pancreatic Fistula after Pancreatoduodenectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- per the ISGPS definition
研究概览
简要总结
Although different surgical approaches are currently used for PD (Pancreatoduodenectomy), there does not seem to be an optimal technique that significantly decreases POPF rates [1]. Despite postoperative mortality rates having significantly decreased to less than 5%, PD may still be associated with relevant morbidity, mainly related to POPF (Post-Operative Panceatic Fistula) (2,3). Various studies have evaluated the role of application of sealant patches in prevention of POPF after pancreaticoojejunostomy . However only few studies study till date has evaluated the efficacy of e PTFE sutures in preventing CR-POPF (Clinically-Relevant Post-Operative Panceatic Fistula) after pancreatoduodenectomy in the Indian scenario
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing Pancreatoduodenectomy with duct-to-mucosa Pancreaticojejunostomy
- •Benign or Malignant etiologies
- •More than or equal to 18 years of age.
排除标准
- •Dunking type of pancreaticojejunostomy
- •Pancreaticogastrostomy.
结局指标
主要结局
per the ISGPS definition
时间窗: 1 week
Development of Clinically Relevant Post
时间窗: 1 week
Operative Pancreatic Fistula (type B and C) as
时间窗: 1 week
次要结局
- 1. Duration of stay in the intensive care unit (ICU).(2. Duration of post-operative hospital stay.)
研究者
Pavithran T
All India Institute of Medical Sciences, Jodhpur