Application of Laparoscopy in Gastrointestinal Injury

October 8, 2017 updated by: Prof. Zongguang Zhou

Study of Laparoscopy in Gastrointestinal Injury

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Chinese PLS General Hospital
        • Contact:
        • Principal Investigator:
          • Lin Chen
      • Chongqing, China
        • Recruiting
        • Southwest Hospital, The 3rd Militory Medical University
        • Contact:
        • Principal Investigator:
          • Peiwu Yu
    • Shanxi
      • Xian, Shanxi, China
        • Not yet recruiting
        • Xijing Hospital, The 4th Militory Medical University
        • Contact:
        • Principal Investigator:
          • Kefeng Dou
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
          • Zongguang zhou, MD., PhD.
          • Phone Number: 18980601007
          • Email: zhou767@163.com
        • Principal Investigator:
          • Zongguang Zhou, MD., PhD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 3 month after operation
3 month after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: 1 month
1 month
Number of iatrogenic injury during the operation
Time Frame: at the end of the operation
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
up to 3 months
Operative time
Time Frame: at the end of the operaion
at the end of the operaion
Blood loss during the operation
Time Frame: at the end of the operation
at the end of the operation
Number of patients transferred to open operation
Time Frame: at the end of the operation
at the end of the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Zongguang Zhou

Investigators

  • Study Chair: Zongguang Zhou, MD., PhD, West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

November 11, 2013

First Submitted That Met QC Criteria

November 20, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Actual)

October 10, 2017

Last Update Submitted That Met QC Criteria

October 8, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LGI-201302016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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