Comparison of sonography and laparoscopy for diagnosis of intraabdominal bleeding and organ injury in patients suffering from thoracoabdominal stab wound
Comparison of the results of sonography and laparoscopy in the diagnosis of intraabdominal hemorrhage and abdominal visceral injury in patients suffering from thoracoabdominal stab wound.
To find the safety and efficacy of FAST as a noninvasive and safe diagnostic method for evaluating diaphragmatic injury in these patients, which reduces the cost of treatment and the time of admission.
Design
An open-label, single arm, and single-center clinical trial on 30 patients.
Settings and conduct
A chest CT scan is done for all studied patients in the emergency department of the Besat hospital, Hamadan, Iran. In patients with the evidence of haemothorax and/or pneumothorax in chest CT scan, a FAST is performed. Then, the patients undergo a diagnostic laparoscopy. under general anesthesia in the operating room. The results of ultrasonography for trauma are compared by comparing the results of diagnostic laparoscopy. If any of the results of the aforementioned diagnostic methods is positive, the patient will be the candidate for the laparotomy to determine the cause and treatment of bleeding and diaphragmatic injury.
Participants/Inclusion and exclusion criteria
Inclusion: patients with thoracoabdominal stab wound and the evidence of hemothorax and/or pneumothorax in chest CT scan.
Exclusion: unstable patients, patients with stab wound in areas other than the thoracoabdominal space, patients with past medical history of COPD or heart failure
Intervention groups
All patients undergo FAST and diagnostic laparoscopy for diagnosis of diaphragmatic injury.
Main outcome variables
FAST results; laparoscopy results; hospital days,
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181201041808N1
Registration date:2019-03-04, 1397/12/13
Registration timing:registered_while_recruiting
Last update:2019-03-04, 1397/12/13
Update count:0
Registration date
2019-03-04, 1397/12/13
Registrant information
Name
Amir Kasraianfard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3264 0020
Email address
kasraianfard@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-11, 1397/12/20
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
2018-06-10, 1397/03/20
Actual recruitment end date
2019-06-20, 1398/03/30
Trial completion date
2018-12-21, 1397/09/30
Scientific title
Comparison of sonography and laparoscopy for diagnosis of intraabdominal bleeding and organ injury in patients suffering from thoracoabdominal stab wound
Public title
Comparison of sonography and laparoscopy for diagnosis of intraabdominal bleeding and organ injury in patients suffering from thoracoabdominal stab wound
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients suffering from stab wound in the thoracoabdominal area defined as the space between 4th intercostal space anteriorly, 6th intercostal space laterally, 8th intercostal posteriorly and the lower edge of the ribs inferiorly.
Patients with hemothorax and/or pneumothorax visible in the chest computed tomography scan.
Exclusion criteria:
Unstable patients
Patients with history of diaphragmatic injury which has not been treated.
Patients with stab wound in areas other than the thoracoabdominal area
Patients with no evidence of hemothorax or pneumothorax in chest CT scan
Patients with past medical history of COPD or heart failure
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
29
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamedan University of Medical Sciences
Street address
Ethics Committee in Research, Faculty of Research & Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Blvd, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2018-06-09, 1397/03/19
Ethics committee reference number
IR.UMSHA.REC.1397.169
Health conditions studied
1
Description of health condition studied
Comparison of sonography and laparoscopy for the diagnosis of intra abdominal bleeding and abdominal visceral injury
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Free fluid in the abdomen - Abdominal visceral injury - Diaphragmatic injury
Timepoint
Early after stab wound
Method of measurement
Focused assessment with sonography for trauma - Laparoscopy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: FAST and laparoscopy- FAST: using the Probe of the Affiniti 50 ultrasound device manufactured by the Phillips Netherlands - Viewing the Morrison (between the liver and the right kidney), splenorenal (between the spleen and the left kidney) and the pelvis spaces for free fluid- Laparoscopy: diagnostic laparoscopy with Karl Storz Laparoscopy Made in Germany - Installing a 15mm port under the umbilical cord and inserting the camera through this port, and fully observing the abdominal spaces and organs and diaphragms
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Amir Kasraianfard
Street address
Shahid Beheshti Blvd, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6514845417
Phone
+98 81 3264 0020
Fax
+98 81 3264 0020
Email
amirkasraian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Vice Chancellor for Research and Technology, Hamadan University of Medical Sciences, Shaheed fahmideh Blvd., Hamadan, Iran
City
hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0717
Email
Vc_research@umsha.ac.ir
Web page address
http://research.umsha.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?