Application of Laparoscopy in Gastrointestinal Injury
- Conditions
- Gastrointestinal Injury
- Interventions
- Procedure: Laparoscopy
- Registration Number
- NCT01994148
- Lead Sponsor
- Prof. Zongguang Zhou
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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.
- Severe hemorrhage or intraperitoneal infections
- Combined with other conditions which are contraindications to laparoscopy
- Pregnant or lactating woman
- Severe immunodeficiency
- History of drug abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Laparoscopy 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.
- Primary Outcome Measures
Name Time Method Mortality 3 month after operation
- Secondary Outcome Measures
Name Time Method Blood loss during the operation at the end of the operation Number of iatrogenic injury during the operation at the end of the operation Number of patients with postoperative complications up to 3 months Postoperative complications include bowel obstruction, wound infection, postoperative hemorrhage,intestine fistula
Operative time at the end of the operaion Length of hospital stay 1 month Number of patients transferred to open operation at the end of the operation
Trial Locations
- Locations (4)
Xijing Hospital, The 4th Militory Medical University
🇨🇳Xian, Shanxi, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Chinese PLS General Hospital
🇨🇳Beijing, China
Southwest Hospital, The 3rd Militory Medical University
🇨🇳Chongqing, China