Laparoscopy (to Detect Occult Diaphragm Injury) Versus Clinical and Radiological Follow up to Detect Diaphragm Injury and Herniation, in Patients With Asymptomatic Left Thoracoabdominal Stab Wounds: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- To assess the clinical outcome of potential occult diaphragm injuries in patients presenting at the Groote Schuur trauma centre with left sided thoracoabdominal stab wounds, if an expectant non operative management course is taken.
研究概览
简要总结
Title: A randomized prospective study comparing non operative management with laparoscopic treatment in patients with a diaphragm injury following left thoracoabdominal stab wounds.
Aim of the Study: The aim of this study is to access the clinical outcome of potential occult diaphragm injuries in a group of patients presenting at the Groote Schuur trauma centre with left sided thoracoabdominal stab wounds, if an expectant non operative management course is taken.
Objects of the Study: To obtain the above mentioned aim the study will undertake;
- to do laparoscopy on a group of randomly selected patients with left thoracoabdominal stab wounds to obtain the incidence of occult diaphragm injury.
- to assess the incidence and clinical outcome of delayed diaphragm visceral herniation in the study group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemodynamically stable patients
- •Patients with penetrating stab wounds bounded by
- •Superiorly the 4th intercostal space
- •Lateral the tip of the left scapula
- •Inferior by the left costal margin
- •Medially by the sternum
- •Signed informed consent
排除标准
- •Hemodynamically unstable patients
- •Previous penetrating injury to the area mentioned under inclusion criteria
- •Patients requiring early surgical exploration for injuries other than diaphragm injuries
- •If a diaphragm injury is detected on imaging
- •A positive pregnancy test
结局指标
主要结局
To assess the clinical outcome of potential occult diaphragm injuries in patients presenting at the Groote Schuur trauma centre with left sided thoracoabdominal stab wounds, if an expectant non operative management course is taken.
时间窗: 2 years
次要结局
未报告次要终点
研究者
PH NAVSARIA
Assoc Professor
University of Cape Town