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临床试验/NCT04401722
NCT04401722已完成不适用

Clinical Impact of Altitude Level on Surgical Outcomes of Pancreaticoduodenectomy for Periampullary Tumour (Multicenter Study)

Mansoura University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
the overall postoperative complications

研究概览

简要总结

Very few papers examine the effect of living at high altitudes on surgical results of major operations. This research is designed to determine the surgical outcomes of PD for periampullary tumour in high altitudes and normal altitudes.

详细描述

Many recent studies have suggested multiple risk factors affecting postoperative surgical outcomes of PD; THE research is designed to determine the surgical outcomes of PD for periampullary tumour in high altitudes and normal altitude.

it is a multicenter study Aseer central hospital, Saudia and from Egypt two centers Mansoura university and el Menia university

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

OUTCOME ASESSOR

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •periampulary tumour

排除标准

  • •liver cirrhosis,
  • •advanced tumour,
  • •vascular resection

研究组 & 干预措施

PD in normal altitude

Active Comparator

PD underwent in the area at the level of the sea, normal altitude region

干预措施: PANCREATICODUDENECTOMY (Procedure)

PD in high altitude region.

Active Comparator

PD underwent in high altitude region.

干预措施: PANCREATICODUDENECTOMY (Procedure)

结局指标

主要结局

the overall postoperative complications

时间窗: 30 DAYS

the overall postoperative complications

次要结局

  • blood loss(INTRAOPERATIVE)
  • hospital mortality(30 days)
  • Pulmonary embolism (PE)(30 days)

研究者

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

Ayman El Nakeeb

gastrointestinal surgical center, Mansoura University

Mansoura University

研究点 (1)

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