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临床试验/NCT01460550
NCT01460550Unknown3 期

Comparison Between Antecolic and Retrocolic Gastrointestinal Reconstruction in Delayed Gastric Emptying After Pancreaticoduodenectomy: A Prospective Randomized Controlled Multicenter Trial

Kobe University2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2011年11月最近更新:
适应症

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

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

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Ippei Matsumoto

Associate Professor

Kobe University

研究点 (2)

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