Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2014-01-31
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Laparoscopy
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.
Interventions
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Laparoscopy
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.
Eligibility Criteria
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Inclusion Criteria
* Blood loss \< 1000ml
* Hemodynamically stable
* Vital sign is stable
* Willing to comply to the study procedure and complete the study.
Exclusion Criteria
* Combined with other conditions which are contraindications to laparoscopy
* Pregnant or lactating woman
* Severe immunodeficiency
* History of drug abuse
18 Years
60 Years
ALL
No
Sponsors
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Prof. Zongguang Zhou
OTHER
Responsible Party
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Prof. Zongguang Zhou
Director of gastrointestinal surgery center, WestChina Hospital
Principal Investigators
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Zongguang Zhou, MD., PhD
Role: STUDY_CHAIR
West China Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Kefeng Dou, MD., PhD
Role: primary
Zongguang zhou, MD., PhD.
Role: primary
Lin Chen, MD., PhD.
Role: primary
Peiwu Yu, MD., PhD
Role: primary
Other Identifiers
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LGI-201302016
Identifier Type: -
Identifier Source: org_study_id