VATS Evacuation Compared to Reinsertion of Thoracostomy Tube in Persistent Traumatic Haemothorax
Primary Purpose
Hemothorax; Traumatic
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
VATS evacuation
thoracostomy tube
Sponsored by
About this trial
This is an interventional treatment trial for Hemothorax; Traumatic
Eligibility Criteria
Inclusion Criteria:
We include for the study all patients admitted to Assiut university hospitals during the time of the study that proved persistent haemothorax that with criteria:
- Ages that are eligible for study are between 18years to 60 years (adult)
- Both genders will be included to study.
- Clinical and radiological diagnosis of persistent haemothorax.
- Thoracostomy tube blockage or failure to drain within 5-7days.
Exclusion Criteria:
- More than one thoracostomy tube drainage in the same attempt side.
- Unable to consent to trial.
- Coexisting pathology requiring other interventions.
- Patients that need urgent interventions (hemodynamically unstable, empyema and flail chest).
Sites / Locations
- Assiut universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
VATS evacuation
thoracostomy tube
Arm Description
patients selected for VATS after failure of first thoracostomy tube drainage
patients selected for thoracostomy tube reinsertion after failure of drainage with first thoracostomy tube
Outcomes
Primary Outcome Measures
Duration of hospitalization
number of days spent
Secondary Outcome Measures
number of patients developed empyema
the study will be monitored for septic complications , specially empyema.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03501524
Brief Title
VATS Evacuation Compared to Reinsertion of Thoracostomy Tube in Persistent Traumatic Haemothorax
Official Title
Video_ Assisted Thoracoscopic Surgery Evacuation Compared to Reinsertion of Thoracostomy Tube in Persistent Traumatic Haemothorax
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Anticipated)
Study Completion Date
July 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is prospective, randomized study comparing VATS (video- Assisted Thoracoscopy) to reinsertion of a thoracostomy tube in patients with persistent traumatic haemothorax. The incidence varies and can be as high as 20%, but in most studies is found to be 1-4% after initial tube thoracostomy for chest trauma. The most accepted complication of retained hemothorax is empyema.Retained hemothorax treatment started by physiotherapy and early withdrawal of tube thoracostomy which lead to more complications as empyema, fibro thorax/entrapped lung, flail chest and diaphragmatic hernia. Early VATS is an alternative treatment for retained hemothorax with evidence that it is a superior intervention when compared to a second tube thoracostomy.
Detailed Description
Traumatic injuries are a significant cause of morbidity and mortality in our society.At Assiut university hospitals, chest injuries (17.7%) considered as second cause of mortality after head injuries (34.6%) of registered deaths by cause of injury at trauma unit, Assiut university hospitals in a study conducted between,2002-2009. In United States, thoracic injuries are the primary factor in approximately 35% of these deaths, one -third of which occur immediately following the injury, and are contributing in nearly 75% of trauma -related deaths. Up to 15% of patients who sustain thoracic trauma undergo emergent thoracotomy for resuscitation, massive hemothorax, cardiac tamponade, large thoracic wounds, major thoracic vascular injuries, tracheobronchial injuries, or evidence of esophageal injury. The remaining 85-90% of patients who reach the emergency department does not require emergent thoracotomy are initially managed with tube thoracostomy, pain control, pulmonary toilet, and observation .Patients failing this management ultimately require elective thoracotomy for further evaluation and treatment(clotted hemothorax, empyema and diaphragmatic hernia. The current role of VATS in trauma includes evaluation and control of continued chest tube bleeding, early evacuation of retained hemothorax, evacuation and decortication of posttraumatic empyemas, evaluation and limited treatment of suspected diaphragm injuries, evaluation and treatment of persistent air leaks, and evaluation of mediastinal injuries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemothorax; Traumatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VATS evacuation
Arm Type
Experimental
Arm Description
patients selected for VATS after failure of first thoracostomy tube drainage
Arm Title
thoracostomy tube
Arm Type
Experimental
Arm Description
patients selected for thoracostomy tube reinsertion after failure of drainage with first thoracostomy tube
Intervention Type
Device
Intervention Name(s)
VATS evacuation
Intervention Description
the patient will be randomized to a Video-Assisted thoracoscopy for retained haemothorax
Intervention Type
Device
Intervention Name(s)
thoracostomy tube
Other Intervention Name(s)
intercostal tube reinsertion
Intervention Description
the patient is randomized to reinsertion of a Thoracostomy Tube for retained haemothorax
Primary Outcome Measure Information:
Title
Duration of hospitalization
Description
number of days spent
Time Frame
average 5-7 days
Secondary Outcome Measure Information:
Title
number of patients developed empyema
Description
the study will be monitored for septic complications , specially empyema.
Time Frame
through one month
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:
We include for the study all patients admitted to Assiut university hospitals during the time of the study that proved persistent haemothorax that with criteria:
Ages that are eligible for study are between 18years to 60 years (adult)
Both genders will be included to study.
Clinical and radiological diagnosis of persistent haemothorax.
Thoracostomy tube blockage or failure to drain within 5-7days.
Exclusion Criteria:
More than one thoracostomy tube drainage in the same attempt side.
Unable to consent to trial.
Coexisting pathology requiring other interventions.
Patients that need urgent interventions (hemodynamically unstable, empyema and flail chest).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed Emad Eldin Omar
Phone
02010065327099
Email
mhmd_rabab@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hussein Khairy Abd_El Aziz Elkhayt, PHD
Phone
0201005549653
Email
dr_Khayt@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Khalil salama Ayyad, PHD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
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VATS Evacuation Compared to Reinsertion of Thoracostomy Tube in Persistent Traumatic Haemothorax
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