The comparison of Thoracotomy with Video-Assisted Thoracoscopic Surgery in treatment of grade II pleural empyema
Design
A non-randomized clinical trial with a parallel control group designed and enrolled in 42 patients.
Settings and conduct
The procedures were done in the operation room of Ayatollah Roohani Hospital in Babol city.
Participants/Inclusion and exclusion criteria
Patients who were admitted with grade II empyema according to chest X-ray and pleural tap, despite the chest tube insertion, drainage, and pulmonary expansion have not been established were included in the trial. Also, the interval between the onset of symptoms and intervention was up to 6 weeks.
patient with an unstable clinical condition, below 15 years old, immunocompromised state, positive pleural cytology for malignancy were excluded from the study.
Intervention groups
Patients in the intervention group were undergone Video-Assisted Thoracoscopic Surgery.
Patients in the control group were undergone thoracotomy.
Main outcome variables
Complete lung expansion rate, Post-operation duration of hospitalization, Operation duration time, Post-operation pain level, Convert rate to thoracotomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190202042594N1
Registration date:2019-05-07, 1398/02/17
Registration timing:retrospective
Last update:2019-05-07, 1398/02/17
Update count:0
Registration date
2019-05-07, 1398/02/17
Registrant information
Name
morteza yaghini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8301
Email address
drmortezayaqini@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
2017-10-23, 1396/08/01
Actual recruitment end date
2019-02-19, 1397/11/30
Trial completion date
2019-02-19, 1397/11/30
Scientific title
Comparison of Thoracotomy and Video Assisted Thoracoscopic Surgery in the treatment of Grade II pleural Empyema
Public title
Comparison of Thoracotomy and Video Assisted Thoracoscopic Surgery in the treatment of Grade II pleural Empyema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have complained of pleural effusion and after radiography and confirmation, have been diagnosed with Tap and have been classified as grade 2 empyema, which despite the introduction of the chest tube, drainage and pulmonary distension have not completely occurred.
The interval between the onset of symptoms and the procedure is up to 6 weeks
Exclusion criteria:
Patients with immune deficiency and consumption of immunosuppressive drugs
Unstable patients
age below 15 years old
positive cytology of plural fluid for malignancy
Age
From 15 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned to one of the two treatment groups based on the admission date serially.
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 Babol University of Medical Sciences
Street address
GanjAfrooz street, Babol university of medical sciences
City
Babol
Province
Mazandaran
Postal code
47745-47176
Approval date
2018-11-18, 1397/08/27
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.185
Health conditions studied
1
Description of health condition studied
Empyema
ICD-10 code
J86
ICD-10 code description
Pyothorax
Primary outcomes
1
Description
Complete lung expansion rate
Timepoint
During 24 h after surgery
Method of measurement
According to chest X-ray
Secondary outcomes
1
Description
Post-operation duration of hospitalization
Timepoint
After discharge from hospital
Method of measurement
Post-operation hospitalization day/days
2
Description
Operation duration time
Timepoint
Just after surgery
Method of measurement
The difference between the start and end time of the surgery
3
Description
Post-operation pain level
Timepoint
Every day after surgery until discharge, once a day
Method of measurement
according to Visual Analogue Scale
Intervention groups
1
Description
Intervention group: Video-assisted thoracoscopic surgery
Category
Treatment - Surgery
2
Description
Control group: posterolateral thoracotomy surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital (Babol)
Full name of responsible person
Ramin Nosrati
Street address
Ayatollah Rouhani hospital, GanjAfrooz, Babol
City
Babol
Province
Mazandaran
Postal code
4774547176
Phone
+98 11 3219 9592
Email
R.nosrati@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Babol university of medical sciences, GanjAfrooz street, Babol
City
Babol
Province
Mazandaran
Postal code
4774547146
Phone
+98 11 3219 9592
Email
r.nosrati@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice-chancellor for research, school of medicine, Babol university of medical sciences
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
Babol University of Medical Sciences
Full name of responsible person
Morteza Yaqini
Position
Surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Darya 26 avenue, Taleb-Amoli street
City
Amol
Province
Mazandaran
Postal code
4615868358
Phone
+98 11 4425 0204
Email
Drmortezayaqini@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Ramin Nosrati
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Ganj afrouz St. babol university of merdical science
City
Babol
Province
Mazandaran
Postal code
4774547176
Phone
+98 11 3219 9592
Email
r.nosrati@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Ramin Nosrati
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
ganjafrouz st. babol university of medical science
City
babol
Province
Mazandaran
Postal code
4774547176
Phone
+98 11 3219 9592
Email
r.nosrati@mubabol.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In this study, all clinical and demographic data are encoded in SPSS software for sharing.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Doctors and people working in academic institutions related to medical sciences
Under which criteria data/document could be used
Use of this research data will be permitted in meta-analysis studies
From where data/document is obtainable
Contact: drmortezayaqini@gmail.com, to receive the data
What processes are involved for a request to access data/document
The applicant will be contacted within 48 hours, and if the academic and employment records of the research environment are properly submitted, research data will be provided to the applicant upon confirmation of the identity of the originator.