Comparison Between Antecolic and Retrocolic Gastrointestinal Reconstruction in Delayed Gastric Emptying After Pancreaticoduodenectomy: A Prospective Randomized Controlled Multicenter Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Incident rate of delayed gastric emptying
研究概览
简要总结
The purpose of this study is to evaluate the incidence of delayed gastric emptying in patient with pancreaticoduodenectomy between antecolic and retrocolic gastrointestinal reconstruction.
详细描述
The purpose of this study is to evaluate the incidence of delayed gastric emptying in patient with pancreaticoduodenectomy between antecolic and retrocolic gastrointestinal reconstruction. Delayed gastric emptying after pancreaticoduodenectomy is important to affect the postoperative course and QOL. We conducted a prospective randomized trial on 240 patients who underwent pancreaticoduodenectomy for comparing between antecolic and retrocolic gastrointestinal reconstruction.
The primary endpoint was defined as incidence of delayed gastric emptying by ISGPS criteria. The secondary endpoint was defined as incidence of other postoperative morbidity. Patients were recruited into this study before surgery, on the basis of whether pancreatic head resection was anticipated for pancreatic head and periampullary disease, and an appropriate informed consent was obtained. Exclusion criteria was 1) patients who have the history of gastrectomy, 2) patients who have severe cardiorespiratory dysfunction, 3) patients who have liver cirrhosis or are receiving dialysis, and 4) patients who were diagnosed inadequate for this study by a physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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 pancreatic-biliary disease who undergo pancreaticoduodenectomy
排除标准
- •patients who have the history of gastrectomy
- •patients who have severe cardiorespiratory dysfunction
- •patients who have liver cirrhosis or are receiving dialysis
- •patients who were diagnosed inadequacy for this study by a physician
结局指标
主要结局
Incident rate of delayed gastric emptying
时间窗: during hospital stay after surgery, an expected average of 3 weeks
DGE represents the inability to return to a standard diet by the end of the first postoperative week and includes prolonged nasogastric intubation of the patient. Three different grades (A,B,and C) were defined based on the impact on the clinical course and on postoperative management by ISGPS.
次要结局
未报告次要终点
研究者
Ippei Matsumoto
Associate Professor
Kobe University
