Randomized Clinical Trial for Evaluation of the Use of Nasogastric Tube Decompression After Pancreatic Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time to flatus
研究概览
简要总结
Introduction: The value of routine nasogastric tube (NGT) decompression after pancreatic surgeries is not yet established. Previous studies in the setting of abdominal surgery suggested that the use of NGT does not accomplish any of its intended goals.
Methods/design: This is a prospective, randomized, controlled multicenter trial with two treatment arms. One group underwent pancreatic surgeries with routine NGT and was left in place after surgery until the patient passed flatus or stool. The other group underwent pancreatic surgeries without receiving NGT decompression, in which the NGT was removed at the end of surgery.
Discussion: Routine NGT decompression after pancreatic surgeries does or does not appear to have its anticipated advantages would be discovered in this RCT.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with age between 18 - 80 years.
- •Patients underwent any kind of pancreatic surgeries, including but not limited to PD, distal pancreatectomy, central pancreatectomy, pancreatic enucleation, etc.
- •Patients accepted the trial and could completed a written consent.
排除标准
- •Combined with digestive tract obstruction before the surgery.
- •History of upper abdominal surgery.
- •Serious heart, brain, lung, metabolic diseases history.
- •Pregnant women.
- •Unwillingness or inability to consent for the study.
结局指标
主要结局
Time to flatus
时间窗: 24 months
It's described as the time patients to get flatus after operation
次要结局
- Pulmonary complication(24 months)
- Incisional hernia(24 months)
- Wound infection(24 months)
- Anastomotic leak(24 months)
- Length of Stay(24 months)
- Gastric upset(24 months)
研究者
Renyi Qin
Clinical professor
Tongji Hospital