Application of Laparoscopy in Gastrointestinal Injury

Study Overview
=================
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.

Official Title
-----------------
Study of Laparoscopy in Gastrointestinal Injury

Conditions
-----------------
Gastrointestinal Injury

Intervention / Treatment
-----------------
* Procedure: Laparoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopy<br>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. | Procedure: Laparoscopy<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 3 month after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of iatrogenic injury during the operation |  | at the end of the operation | 
| Number of patients with postoperative complications | Postoperative complications include bowel obstruction, wound infection, postoperative hemorrhage,intestine fistula | up to 3 months | 
| Operative time |  | at the end of the operaion | 
| Blood loss during the operation |  | at the end of the operation | 
| Length of hospital stay |  | 1 month | 
| Number of patients transferred to open operation |  | at the end of the operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trauma, Gastrointestinal injury, Laparoscopy