Comparison the success rate of two different treatment procedures (simple drainage with chest tube and surgical debridement) in dealing with patients with empyema following complicated pneumonia
Design
This study is a randomized clinical trial. The statistical population consists of 104 patients with second phase empyema who are admitted to the hospital. The patients are alternately divided into two groups, each of 52, in the order of hospitalization.
Settings and conduct
This study is carried out in Surgery Department of Imam Khomeini Hospital in Tabriz and Shariaati Hospital in Isfahan. After hospitalization, the patients are divided into two groups; one group is treated with simple thoracostomy and the other group with surgical debridement.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with parapneumonic empyema;
patients should be in the second phase of the empyema;
Exclusion criteria:
impossibility of anesthesia due to the associated conditions that increases the risk of surgical treatment;
the presence of bronchopleural fistula;
empyema with multiple loculations that is not treated only using the chest tube;
empyema in the first or fifth phase;
empyema after surgery or trauma.
Intervention groups
one group has undergone open or thoracoscopic surgical procedure for drenaging empyema and debridment of the loculations and the other group is treated with simple tube thoracostomy
Main outcome variables
Complications (fever, respiratory distress and difficulty in breathing), duration of treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170504033818N2
Registration date:2018-07-27, 1397/05/05
Registration timing:retrospective
Last update:2018-07-27, 1397/05/05
Update count:0
Registration date
2018-07-27, 1397/05/05
Registrant information
Name
Behnam Yazdani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4229 1111
Email address
dr.yazdani@pmd.iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
treatment is covered by social insurance and patients will be treated free in hospital and research costs are provided by the researcher.
Expected recruitment start date
2003-08-23, 1382/06/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
2003-08-23, 1382/06/01
Actual recruitment end date
2015-08-23, 1394/06/01
Trial completion date
empty
Scientific title
simple tube thoracostomy versus surgical debridement in complicated parapneumonic empyema management
Public title
simple tube thoracostomy versus surgery in pleural infection management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
suffering from empyema - that has been proved using pleural fluid aspiration - due to the fluid accumulation following pneumonia
undergoing the second phase of the empyema
Exclusion criteria:
impossibility of anesthesia due to the associated conditions that increases the risk of surgical treatment
the presence of bronchopleural fistula
empyema with multiple loculations that is not treated only using the chest tube.
empyema in the first or third phase
empyema after surgery or trauma
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
104
Actual sample size reached:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are alternately divided into two groups in the order of hospitalization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2017-01-09, 1395/10/20
Ethics committee reference number
ir.tbzmed.rbc.1395.1278
Health conditions studied
1
Description of health condition studied
empyema
ICD-10 code
J86
ICD-10 code description
Pyothorax
2
Description of health condition studied
empyema after pneumonia
ICD-10 code
J18.9
ICD-10 code description
Pneumonia, unspecified
3
Description of health condition studied
pleural effusion
ICD-10 code
J90
ICD-10 code description
Pleural effusion, not elsewhere classified
4
Description of health condition studied
empyema without fistula
ICD-10 code
J86.9
ICD-10 code description
Pyothorax without fistula
Primary outcomes
1
Description
complications after discharge
Timepoint
one week and one month
Method of measurement
Fever, respiratory distress and difficulty in breathing
2
Description
duration of each treatment procedure
Timepoint
from the beginning of the patient’s admission to the end of the medication taking
Method of measurement
the number of the recorded days
Secondary outcomes
1
Description
Recurrence after recovery
Timepoint
one week and one month after discharge
Method of measurement
signs , symptoms and paraclinical results
2
Description
The duration of hospitalization
Timepoint
The date of admission to patient discharge
Method of measurement
the number of the recorded days
3
Description
the duration of having chest tube
Timepoint
From the chest tube insertion to its removal
Method of measurement
the number of the recorded days
4
Description
duration of each treatment procedure
Timepoint
from the beginning of the patient’s admission to the end of the medication taking
Method of measurement
the number of the recorded days
Intervention groups
1
Description
The intervention group are treated by a simple Tube Thoracostomy .
Category
Treatment - Surgery
2
Description
The control group are prepared for surgery and undergo debridement for draining empyema and inserting the chest tube.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Behnam Yazdani
Street address
Shariati Street
City
Isfahan
Province
Isfehan
Postal code
8173745384
Phone
+98 31 3627 2001
Email
yazdanibehnam@yahoo.com
2
Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Behnam Yazdani
Street address
Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166615573
Phone
+98 41 3337 3907
Email
yazdanibehnam@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University Najafabad Branch
Full name of responsible person
Behnam Yazdani
Street address
Shariati hospital
City
Isfahan
Province
Isfehan
Postal code
8173745384
Phone
+98 31 3627 2001
Email
yazdanibehnam@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Najafabad Branch
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University Najafabad Branch
Full name of responsible person
Shima jafari jebeli
Position
medical intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Shariati Hospital
City
Isfahan
Province
Isfehan
Postal code
8173745384
Phone
+98 31 3627 2001
Fax
Email
shimajafari8998@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Najafabad Branch
Full name of responsible person
Behnam Yazdani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
thorax surgery
Street address
Dr shariati Hospital
City
Isfahan
Province
Isfehan
Postal code
8173745384
Phone
+98 31 3628 1630
Fax
Email
dr.yazdani@pmd.iaun.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Najafabad Branch
Full name of responsible person
Behnam Yazdani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shariati hospital
City
Isfahan
Province
Isfehan
Postal code
8173745384
Phone
+98 31 3628 1630
Fax
Email
dr.yazdani@pmd.iaun.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available