Application of Laparoscopy in Gastrointestinal Injury
|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
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Injury||Procedure: Laparoscopy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- Mortality [ Time Frame: 3 month after operation ]
- Number of iatrogenic injury during the operation [ Time Frame: at the end of the operation ]
- Number of patients with postoperative complications [ Time Frame: up to 3 months ]Postoperative complications include bowel obstruction, wound infection, postoperative hemorrhage,intestine fistula
- Operative time [ Time Frame: at the end of the operaion ]
- Blood loss during the operation [ Time Frame: at the end of the operation ]
- Length of hospital stay [ Time Frame: 1 month ]
- Number of patients transferred to open operation [ Time Frame: at the end of the operation ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994148
|Contact: Zongguang Zhou, MD., PhD.||email@example.com|
|Contact: Yuan Yin, MD.||firstname.lastname@example.org|
|Xijing Hospital, The 4th Militory Medical University||Not yet recruiting|
|Xian, Shanxi, China|
|Contact: Kefeng Dou, MD., PhD email@example.com|
|Principal Investigator: Kefeng Dou|
|West China Hospital, Sichuan University||Recruiting|
|Chengdu, Sichuan, China, 610041|
|Contact: Zongguang zhou, MD., PhD. 18980601007 firstname.lastname@example.org|
|Principal Investigator: Zongguang Zhou, MD., PhD.|
|Chinese PLS General Hospital||Recruiting|
|Contact: Lin Chen, MD., PhD. email@example.com|
|Principal Investigator: Lin Chen|
|Southwest Hospital, The 3rd Militory Medical University||Recruiting|
|Contact: Peiwu Yu, MD., PhD firstname.lastname@example.org|
|Principal Investigator: Peiwu Yu|
|Study Chair:||Zongguang Zhou, MD., PhD||West China Hospital|