Application of Laparoscopy in Gastrointestinal Injury

Gastrointestinal Injury Clinical Trial

Official title:

Study of Laparoscopy in Gastrointestinal Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01994148
• Other study ID #: LGI-201302016
• Status: Recruiting
• Phase: N/A
• First received: November 11, 2013
• Last updated: October 8, 2017
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: October 2017
• Source: West China Hospital
• Contact: Zongguang Zhou, MD., PhD.
• Phone: 18980601007
• Email: zhou767[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
China	Chinese PLS General Hospital	Beijing
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Southwest Hospital, The 3rd Militory Medical University	Chongqing
China	Xijing Hospital, The 4th Militory Medical University	Xian	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Zongguang Zhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		3 month after operation
Secondary	Number of iatrogenic injury during the operation		at the end of the operation
Secondary	Number of patients with postoperative complications	Postoperative complications include bowel obstruction, wound infection, postoperative hemorrhage,intestine fistula	up to 3 months
Secondary	Operative time		at the end of the operaion
Secondary	Blood loss during the operation		at the end of the operation
Secondary	Length of hospital stay		1 month
Secondary	Number of patients transferred to open operation		at the end of the operation