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临床试验/NCT07274007
NCT07274007进行中(未招募)不适用

Management of Grade III Traumatic Splenic Injury in Hemodynamically Stable Patients ; Laparoscopic Splenectomy Versus Splenic Artery Embolization by Interventional Radiology

Zagazig University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年12月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
24
试验地点
1
主要终点
Number of participants with clinical complications: as pain, fever, leucocytosis, vomiting, or illeus.

研究概览

简要总结

The goal of this clinical trial is selection of the best method in management of grade 3 traumatic Splenic Injury in Hemodynamically Stable Patients thus improving the quality of life and clinical outcome. The main questions it aims to answer are

  1. Assess the quality of life and clinical outcome after using laparoscopic Splenectomy in management of grade 3 traumatic Splenic Injury in Hemodynamically Stable Patients
  2. Assess the quality of life and clinical outcome after using Splenic Artery Embolization in management of grade 3 traumatic Splenic Injury in Hemodynamically Stable Patients

Researchers will compare the quality of life and clinical outcome to see if it is better using laparoscopic Splenectomy Splenic Artery Embolization

Participants will underwent laparoscopic Splenectomy or Splenic Artery Embolization and will undwent post operative follow up, follow up at outpatient clinic and will be asked about changes occurring to their daily life social activities and their quality of life

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged above 12 years at time of screening.
  • Patients diagnosed with grade three traumatic Splenic Injury

排除标准

  • Patients aged less than 12 years at time of screening .
  • Patients diagnosed with associated visceral injury such as "liver,kidney,bowel, etc..".
  • Patients diagnosed with isolated splenic injury after trauma other than grades III
  • Patients contraindicated for radiological investigations or splenic artery embolization using interventional radiology such as pregnany

结局指标

主要结局

Number of participants with clinical complications: as pain, fever, leucocytosis, vomiting, or illeus.

时间窗: 6 months

Number of participants with clinical complications: like Pain, fever, leucocytosis, vomiting, or illeus.

次要结局

  • Recovery time: Length of postoperative hospital stay in days.(6 months.)
  • Measuring post operative pain severity using pain severity score.(6 months.)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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