Study of Laparoscopy in Gastrointestinal Injury
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- Mortality
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Laparoscopy (Procedure)
Outcomes
Primary Outcomes
Mortality
Time Frame: 3 month after operation
Secondary Outcomes
- Number of patients transferred to open 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)
- Operative time(at the end of the operaion)
- Length of hospital stay(1 month)
- Blood loss during the operation(at the end of the operation)
Investigators
Prof. Zongguang Zhou
Director of gastrointestinal surgery center, WestChina Hospital
West China Hospital