Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy : A Prospective and Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Occurrence of Clavien and Dindo complication ≥ grade II
研究概览
简要总结
The use of nasogastric (NG) decompression after pancreaticoduodenectomy (PD) is a current practice. NG tube is associated with a high rate of morbidity including pulmonary morbidity, delayed gastric emptying and finally an increased length of hospital stay.
The absence of NG decompression could be the corner stone of the concept of the enhanced recovery program after PD.
详细描述
The use of nasogastric (NG) decompression after pancreaticoduodenectomy (PD) is a current practice. NG tube is associated with a high rate of morbidity including pulmonary morbidity, delayed gastric emptying and finally an increased length of hospital stay. In the era of the enhance recovery after major abdominal surgery, the place of the NG tube remains unproven after PD even if NG tube is clearly abandoned in liver, stomach and colonic surgery. Nowadays, only few retrospective series had reported the feasibility of the absence of nasogastric tube after PD, but not with a randomized control trial. The absence of NG decompression could be the corner stone of the concept of the enhanced recovery program after PD.
The objective of this prospective randomized monocentric study is to evaluate the impact of the absence of NG decompression after PD.
The aim of the study is to decrease postoperative morbidity after PD including pulmonary and delayed gastric emptying complication. The impact of the absence of systematic NG decompression could be interesting in terms of public health with a decreased of length of hospital stay. Furthermore, this is the first randomized study comparing NG tube decompression after PD to absence of NG tube after PD which would bring relevant elements to improve the recovery after PD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years and ≤ 75 years
- •patient requiring a PD for benign of malign pathology of the bilio and pancreatic intersection
- •patient giving free and informed consent
排除标准
- •previous gastric of esophagus surgery
- •sever comorbidity such as : end stage renal disease, respiratory failure, heart failure (≥ 3 NYHA)
- •Person with a measure of legal protection (guardianship)
- •Pregnant woman or nursing mother
研究组 & 干预措施
With Nasogastric Decompression
This group will receive conventional care according to the protocol of the service in place with removal of the nasogastric tube the 3rd postoperative day if the flow is < 500ml / 24h, if not removal will take place on the 5th postoperative day.
干预措施: nasogastric tube (Device)
Without Nasogastric decompression
The nasogastric tube will be take off at the end of the surgery, just after the extubation.
干预措施: no nasogastric tube (Device)
结局指标
主要结局
Occurrence of Clavien and Dindo complication ≥ grade II
时间窗: up to five days after surgery
during hospitalisation to demonstrate the feasibility of the absence of NG decompression after pancreaticoduodenectomy
次要结局
- Readmission rate(up to 90 days after surgery)
- Gastric emptying(up to five days after surgery)
- Mortality rate(up to 90 days after surgery)
- Hospital stay(up to 90 days after surgery)
- Pulmonary complication(up to 90 days after surgery)
- First gas(up to five days after surgery)
- Food intake(up to five days after surgery)
- Pancreatic fistula(up to 90 days after surgery)
- Reinsertion of Nasogastric tube(up to five days after surgery)