Gastrointestinal Injury Clinical Trial
Official title:
Study of Laparoscopy in Gastrointestinal Injury
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.
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.
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