Outcomes of Reinforcement Patch Around Pancreaticojejunostomy on Clinically Relevant Pancreatic Fistula After Pancreatoduodenectomy- A Randomised Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Development of Clinically Relevant Post Operative Pancreatic Fistula (type B and C) as per the ISGPS definition
研究概览
简要总结
Although different surgical approaches are currently used for pancreatoduodenectomy (PD), there does not seem to be an optimal technique that significantly decreases Post-operative Pancreatic Fistula (POPF) rates. Despite post-operative mortality rates having significantly decreased to less than 5 %, PD may still be associataed with relevant morbidity, mainly related to POPF. Various studies have evaluated the role of application of sealant patches in prevention of POPF after pancreaticojejunostomy. However no study till date has evalluated the efficacy of reinforcement patches [ Combination of Oxidised regenerataed cellulose, Trilysine and Polyethylene Glycol (OTP)] in preventing CR-POPF (Clinically-Relevant Post-Operative Pancreatic Fistula) after pancreatoduodenectomy in the Indian scenario. This study will be the first of its kind.
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
- •â‰¥18 years of age.
排除标准
- •Subjected to multivisceral resection along with Pancreatoduodenectomy
- •Dunking type of pancreaticojejunostomy or Pancreaticogastrostomy
- •Patients who received neoadjuvant therapy
- •Immunosuppressed patients.
结局指标
主要结局
Development of Clinically Relevant Post Operative Pancreatic Fistula (type B and C) as per the ISGPS definition
时间窗: Perioperative period
次要结局
- Duration of intensive care unit (ICU) stay.(2) Duration of post-operative hospital stay.)
研究者
Shaikh Muna Afroz Moizuddin
All India Institute of Medical Sciences, Jodhpur