Antecolic Versus Retrocolic Gastrojejunostomy Following Pancreaticoduodenectomy: a Prospective Randomised Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Delayed Gastric Emptying
研究概览
简要总结
Aim: This randomized clinical study aims to compare occurrence of DGE in patients undergoing either antecolic or retrocolic gastrojejunostomy following pancreaticoduodenectomy.
Methods: Participants of this study will be patients undergoing pylorus preserving pancreaticoduodenectomy at the Surgical Department of the University Hospital of Larissa. Patients will be randomized to undergo either an antecolic or a retrocolic gastrojejunostomy and the occurrence of DGE will then be compared between the two groups. Individuals younger than 18 or older than 75 years old, as well as patients who do not consent to participate in this trial, will be excluded.
Expected results: Based on available literature, antecolic gastrojejunostomy may be related with a lower incidence of DGE, without a statistically significant difference between the two methods. We aim to show if one of the two methods of gastrointestinal reconstruction (antecolic versus retrocolic) affects DGE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Age over 18 years old
- •Elective pancreaticoduodenectomy
- •Signed consent form
排除标准
- •Age under 18 years old
- •Patients who are participants in other trials that may affect the results of this study
- •Patients who do not consent to participate in the study
研究组 & 干预措施
Antecolic gastrojejunostomy
干预措施: Antecolic gastrojejunostomy (Procedure)
Retrocolic gastrojejunostomy
干预措施: Retrocolic gastrojejunostomy (Procedure)
结局指标
主要结局
Delayed Gastric Emptying
时间窗: 3 years
The occurence of delayed gastric emptying will be compared between two groups of patients: those who undergo an antecolic gastrojejunostomy and those who undergo a retrocolic approach.
次要结局
未报告次要终点
研究者
Chrysoula-Christina Kolla
MD, Msc
University of Thessaly
