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Application of Laparoscopy in Gastrointestinal Injury

Primary Purpose

Gastrointestinal Injury

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Laparoscopy
Sponsored by
Prof. Zongguang Zhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Injury focused on measuring Trauma, Gastrointestinal injury, Laparoscopy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xijing Hospital, The 4th Militory Medical University
  • West China Hospital, Sichuan UniversityRecruiting
  • Chinese PLS General HospitalRecruiting
  • Southwest Hospital, The 3rd Militory Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laparoscopy

Arm Description

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.

Outcomes

Primary Outcome Measures

Mortality

Secondary Outcome Measures

Number of iatrogenic injury during the operation
Number of patients with postoperative complications
Postoperative complications include bowel obstruction, wound infection, postoperative hemorrhage,intestine fistula
Operative time
Blood loss during the operation
Length of hospital stay
Number of patients transferred to open operation

Full Information

First Posted
November 11, 2013
Last Updated
October 8, 2017
Sponsor
Prof. Zongguang Zhou
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1. Study Identification

Unique Protocol Identification Number
NCT01994148
Brief Title
Application of Laparoscopy in Gastrointestinal Injury
Official Title
Study of Laparoscopy in Gastrointestinal Injury
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Zongguang Zhou

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Injury
Keywords
Trauma, Gastrointestinal injury, Laparoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopy
Intervention Description
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 Measure Information:
Title
Mortality
Time Frame
3 month after operation
Secondary Outcome Measure Information:
Title
Number of iatrogenic injury during the operation
Time Frame
at the end of the operation
Title
Number of patients with postoperative complications
Description
Postoperative complications include bowel obstruction, wound infection, postoperative hemorrhage,intestine fistula
Time Frame
up to 3 months
Title
Operative time
Time Frame
at the end of the operaion
Title
Blood loss during the operation
Time Frame
at the end of the operation
Title
Length of hospital stay
Time Frame
1 month
Title
Number of patients transferred to open operation
Time Frame
at the end of the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zongguang Zhou, MD., PhD.
Phone
18980601007
Email
zhou767@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Yin, MD.
Phone
15680600588
Email
yinyuan10@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zongguang Zhou, MD., PhD
Organizational Affiliation
West China Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Xijing Hospital, The 4th Militory Medical University
City
Xian
State/Province
Shanxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kefeng Dou, MD., PhD
Email
doukef@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Kefeng Dou
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zongguang zhou, MD., PhD.
Phone
18980601007
Email
zhou767@163.com
First Name & Middle Initial & Last Name & Degree
Zongguang Zhou, MD., PhD.
Facility Name
Chinese PLS General Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Chen, MD., PhD.
Email
chenlinbj@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Lin Chen
Facility Name
Southwest Hospital, The 3rd Militory Medical University
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peiwu Yu, MD., PhD
Email
yupeiwu01@sina.com
First Name & Middle Initial & Last Name & Degree
Peiwu Yu

12. IPD Sharing Statement

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Application of Laparoscopy in Gastrointestinal Injury

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