Application of Laparoscopy in Gastrointestinal Injury
Study of Laparoscopy in Gastrointestinal Injury
研究概览
详细说明
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.
We defined the CT scan positive by it shows peritoneal effusion, free intraperitoneal air, fat density increase, substantive organ rupture and intestinal wall swelling and other signs of abdominal trauma.
Laparoscopic screening will be performed according to protocol. The study demands that all surgeons should complete the repair laparoscopically as much as possible when condition allow, and record reasons for conversion in detail when it is inevitable.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Beijing、中国
- 招聘中
- Chinese PLS General Hospital
-
接触：
- Lin Chen, MD., PhD.
- 邮箱：chenlinbj@vip.sina.com
-
首席研究员：
- Lin Chen
-
Chongqing、中国
- 招聘中
- Southwest Hospital, The 3rd Militory Medical University
-
接触：
- Peiwu Yu, MD., PhD
- 邮箱：yupeiwu01@sina.com
-
首席研究员：
- Peiwu Yu
-
-
Shanxi
-
Xian、Shanxi、中国
- 尚未招聘
- Xijing Hospital, The 4th Militory Medical University
-
接触：
- Kefeng Dou, MD., PhD
- 邮箱：doukef@fmmu.edu.cn
-
首席研究员：
- Kefeng Dou
-
-
Sichuan
-
Chengdu、Sichuan、中国、610041
- 招聘中
- West China Hospital, Sichuan University
-
接触：
- Zongguang zhou, MD., PhD.
- 电话号码：18980601007
- 邮箱：zhou767@163.com
-
首席研究员：
- Zongguang Zhou, MD., PhD.
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Severe hemorrhage or intraperitoneal infections
- Combined with other conditions which are contraindications to laparoscopy
- Pregnant or lactating woman
- Severe immunodeficiency
- History of drug abuse
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
In this study, laparoscopic intervention will be performed under carbon dioxide pneumoperitoneum (pressure, 10-12 mm Hg; flow volume, 8-10 L/min).
A 12-mm trocar will be placed in the umbilicus with use of an open technique and to establish pneumoperitoneum.A 10-mm and a 5-mm trocar will be inserted in the right and left flanks,respectively.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Mortality
大体时间：3 month after operation
|
3 month after operation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
住院时间
大体时间：1个月
|
1个月
|
|
|
Number of iatrogenic injury during the operation
大体时间：at the end of the operation
|
at the end of the operation
|
|
|
Number of patients with postoperative complications
大体时间：up to 3 months
|
Postoperative complications include bowel obstruction, wound infection, postoperative hemorrhage,intestine fistula
|
up to 3 months
|
|
Operative time
大体时间：at the end of the operaion
|
at the end of the operaion
|
|
|
Blood loss during the operation
大体时间：at the end of the operation
|
at the end of the operation
|
|
|
Number of patients transferred to open operation
大体时间：at the end of the operation
|
at the end of the operation
|
合作者和调查者
调查人员
- 学习椅：Zongguang Zhou, MD., PhD、West China Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.