Study of Laparoscopy in Gastrointestinal Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Mortality
研究概览
简要总结
laparoscopy has been increasingly applied in patients with abdominal trauma , as an diagnostic and therapeutic modality. However, its clinical benefits are still under evaluation. The aim of this study is to prospectively assess the feasibility and safety of this technique in the management of traumatic gastrointestinal injury.
详细描述
This prospective single arm study was undertaken in West China Hospital, Sichuan University, Chengdu, China. The institution is the largest medical center in southwest China, and also a national training center of laparoscopy. Surgeons participated in the study were well trained in gastrointestinal laparoscopy and hepatobiliary laparoscopy, and were experienced in management of abdominal trauma.
The study was approved by the institutional review committees. The participants provided written informed consent.
Patients age 18 years or older with abdominal trauma were considered eligible, regardless of the nature of trauma (blunt or penetrating), but hemodynamic stability was mandatory.
Patients meet the following criteria is prepared for laparoscopic exploration:
Evidence showed that wound penetrates the peritoneum in penetrating trauma or/and signs of peritoneal irritation or positive CT scan in those without penetration of peritoneum and patients with blunt injuries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Clinical diagnosis of gastrointestinal trauma
- •Blood loss < 1000ml
- •Hemodynamically stable
- •Vital sign is stable
- •Willing to comply to the study procedure and complete the study.
排除标准
- •Severe hemorrhage or intraperitoneal infections
- •Combined with other conditions which are contraindications to laparoscopy
- •Pregnant or lactating woman
- •Severe immunodeficiency
- •History of drug abuse
研究组 & 干预措施
Laparoscopy
Laparoscopy has been increasingly applied in patients with abdominal trauma , as an diagnostic and therapeutic modality. In this arm, we will include 100 Hemodynamically stable patients with gastrointestinal trauma, all of them will receive laparoscopic exploration,laparoscopic repair of the gastrointestinal injury will be attempted.
干预措施: Laparoscopy (Procedure)
结局指标
主要结局
Mortality
时间窗: 3 month after operation
次要结局
- Blood loss during the operation(at the end of the operation)
- Length of hospital stay(1 month)
- Number of iatrogenic injury during the operation(at the end of the operation)
- Number of patients with postoperative complications(up to 3 months)
- Operative time(at the end of the operaion)
- Number of patients transferred to open operation(at the end of the operation)
研究者
Prof. Zongguang Zhou
Director of gastrointestinal surgery center, WestChina Hospital
West China Hospital