Clinical trial NCT01994148: Application of Laparoscopy in Gastrointestinal Injury
Official title: Study of Laparoscopy in Gastrointestinal Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Injury
Keywords: Trauma
Gastrointestinal injury
Laparoscopy
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mortality
timeFrame: 3 month after operation
Secondary outcomes:
measure: Number of iatrogenic injury during the operation
timeFrame: at the end of the operation
measure: Number of patients with postoperative complications
timeFrame: up to 3 months
measure: Operative time
timeFrame: at the end of the operaion
measure: Blood loss during the operation
timeFrame: at the end of the operation
measure: Length of hospital stay
timeFrame: 1 month
measure: Number of patients transferred to open operation
timeFrame: at the end of the operation
Other outcomes:
Locations:
city: Xian
country: China
facility: Xijing Hospital, The 4th Militory Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Beijing
country: China
facility: Chinese PLS General Hospital
city: Chongqing
country: China
facility: Southwest Hospital, The 3rd Militory Medical University
Study officials:
affiliation: West China Hospital
name: Zongguang Zhou, MD., PhD
role: STUDY_CHAIR
References: