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Application of Laparoscopy in Gastrointestinal Injury

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ClinicalTrials.gov Identifier: NCT01994148
Recruitment Status : Unknown
Verified October 2017 by Prof. Zongguang Zhou, West China Hospital.
Recruitment status was:  Recruiting
First Posted : November 25, 2013
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Zongguang Zhou, West China Hospital

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Injury Procedure: Laparoscopy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Laparoscopy in Gastrointestinal Injury
Study Start Date : January 2014
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: 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.
Procedure: 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.




Primary Outcome Measures :
  1. Mortality [ Time Frame: 3 month after operation ]

Secondary Outcome Measures :
  1. Number of iatrogenic injury during the operation [ Time Frame: at the end of the operation ]
  2. Number of patients with postoperative complications [ Time Frame: up to 3 months ]
    Postoperative complications include bowel obstruction, wound infection, postoperative hemorrhage,intestine fistula

  3. Operative time [ Time Frame: at the end of the operaion ]
  4. Blood loss during the operation [ Time Frame: at the end of the operation ]
  5. Length of hospital stay [ Time Frame: 1 month ]
  6. Number of patients transferred to open operation [ Time Frame: at the end of the operation ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994148


Contacts
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Contact: Zongguang Zhou, MD., PhD. 18980601007 zhou767@163.com
Contact: Yuan Yin, MD. 15680600588 yinyuan10@gmail.com

Locations
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China, Shanxi
Xijing Hospital, The 4th Militory Medical University Not yet recruiting
Xian, Shanxi, China
Contact: Kefeng Dou, MD., PhD       doukef@fmmu.edu.cn   
Principal Investigator: Kefeng Dou         
China, Sichuan
West China Hospital, Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Contact: Zongguang zhou, MD., PhD.    18980601007    zhou767@163.com   
Principal Investigator: Zongguang Zhou, MD., PhD.         
China
Chinese PLS General Hospital Recruiting
Beijing, China
Contact: Lin Chen, MD., PhD.       chenlinbj@vip.sina.com   
Principal Investigator: Lin Chen         
Southwest Hospital, The 3rd Militory Medical University Recruiting
Chongqing, China
Contact: Peiwu Yu, MD., PhD       yupeiwu01@sina.com   
Principal Investigator: Peiwu Yu         
Sponsors and Collaborators
Prof. Zongguang Zhou
Investigators
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Study Chair: Zongguang Zhou, MD., PhD West China Hospital
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Responsible Party: Prof. Zongguang Zhou, Director of gastrointestinal surgery center, WestChina Hospital, West China Hospital
ClinicalTrials.gov Identifier: NCT01994148    
Other Study ID Numbers: LGI-201302016
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Keywords provided by Prof. Zongguang Zhou, West China Hospital:
Trauma
Gastrointestinal injury
Laparoscopy
Additional relevant MeSH terms:
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Wounds and Injuries