Comparison of respiratory capacity and short term complications between single port versus standard diagnostic Video-assisted Thoracoscopy for patients with lung lesions needed to diagnosis
comparison of clinical outcomes between single port and standard diagnostic thoracoscopy
Design
40 patients with lung lesions needy to diagnosis are allocated at non blinded clinical trial.This patients are randomly allocated into two intervention ( single port thoracoscopy) and control (standard thoracoscopy)groups using a balanced block randomization technique.
Settings and conduct
Referral patients to surgical clinic with lung lesions and with an indication for thoracoscopy will be entered into study according to the eligibility criteria and after giving an informed consent. Patients are randomly allocated into two intervention ( single port thoracoscopy) and control (standard thoracoscopy) groups using a balanced block randomization technique. After diagnostic procedure vital capacity, post operative pain, complications and stay in hospital are compared between two groups.
This study is done at Modarres hospital from Shahid Beheshti University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria:patients with lung disease needy to diagnostic thoracoscopy
Exclusion criteria:previous thoracotomy and any condition that prohibits thoracoscopy
Intervention groups
Diagnostic single port thoracoscopy for patients with lung lesion(intervention group);
Diagnostic standard three ports thoracoscopy for patients with lung lesion(control group)
Main outcome variables
Respiratory capacities؛pain after surgery؛complications after surgery؛hospital stay duration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160803029181N5
Registration date:2018-03-06, 1396/12/15
Registration timing:retrospective
Last update:2018-03-06, 1396/12/15
Update count:0
Registration date
2018-03-06, 1396/12/15
Registrant information
Name
Nasser Malekpour Alamdari
Name of organization / entity
Shaid Behesht University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 4089
Email address
nassermalekpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
2017-09-21, 1396/06/30
Actual recruitment end date
2018-01-21, 1396/11/01
Trial completion date
empty
Scientific title
Comparison of respiratory capacity and short term complications between single port versus standard diagnostic Video-assisted Thoracoscopy for patients with lung lesions needed to diagnosis
Public title
Survey of clinical outcomes in single port diagnostic thoracoscopy
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Lung disease needs to diagnostic thoracoscopy
Exclusion criteria:
Previous thoracotomy
Complete collapse Impossibility in intervened sided
Controlateral severe lung disease
Controlateral airway lesion
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
Actual sample size reached:
27
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly enrolled in two groups single port diagnostic thoracoscopy(intervention) and three ports diagnostic thoracoscopy with randomized block technique
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
Ethical committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak; Daneshju Ave; Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-07-28, 1396/05/06
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.331
Health conditions studied
1
Description of health condition studied
Single incision diagnostic thoracoscopy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Respiratory capacities
Timepoint
Admission,discharge,2 weeks later
Method of measurement
Spiropmetry
2
Description
Pain after surgery
Timepoint
Discharge,2 weeks later
Method of measurement
Visual analogue scale
3
Description
Complications after surgery
Timepoint
Discharge,2 weeks later
Method of measurement
Check list
4
Description
Hospital stay
Timepoint
Admission,discharge
Method of measurement
Check list
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who have an indication for thoracoscopy will recieve a single port that is entered into pleural space with a 2.5 cm incision at 5th intercostal space on midaxillary line, and a biopsy will be taken
Category
Diagnosis
2
Description
Control group: Patients who have an indication for thoracoscopy will receive the standard procedure with 3 ports. One 11 mm port at 7th intercostal space on midaxillary line for thoracoscope, and two more 5 mm ports at 4th and 7th intercostal space on posterior axillary line are entered into pleural space and a biopsy will be taken.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Modarres hospital
Full name of responsible person
Nasser Malekpour
Street address
Modarres Hospital;Kaj Sq;Saadat abad;
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2206 9355
Email
nassermalekpour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences;Daneshju Ave;Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
nassermalekpour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour
Position
َAssistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Modarres hospital;Kaj sq;Saadat abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2206 9355
Email
nassermalekpour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Modarres Hospital;Kaj Sq;Saadat Abad
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
nassermalekpour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Modarres Hospital;Kaj Sq;Saadat Abad
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
nassermalekpour@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further data
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