The treatment of esophageal atresia is performed by two different methods that can be used in neonates, a procedure without opening the pleura (extrapleural route) and another method with opening the pleura (Trans plural). Comparison of these methods can be useful for surgeons to choose the best method for esophageal atresia repair with fewer mortality and complications. Comparison of surgical treatment of esophageal atresia in infants Trans plural and extrapleural is the aim of recent trial. Methods: In this project we divide all neonates who have esophageal atresia(type-c) to 2 group; in the study group surgery is done without entrance to pleural space(extrapleural) and in the control, surgery is done Trans plural (by opening the pleura). Comparison of two methods for mortality and complications help us to choose the best method of repair. Most important benefit of this research is to increase patients’ survival and can reduce the mortality and reduce suffering of patients and their parents due to complications or recurrences.
General information
Acronym
Transpleural and extrapleural surgery in esophageal atresia
IRCT registration information
IRCT registration number:IRCT201301315966N1
Registration date:2013-05-03, 1392/02/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-03, 1392/02/13
Registrant information
Name
Omid Amanollahi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 988314276310
Email address
oamanollahi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-11-21, 1392/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of surgery(transpleural and extrapleural)in treatment of esophageal atresia in neonates .
Public title
Comparison of two methods of surgery(transpleural and extrapleural)in treatment of esophageal atresia in neonates .
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: cases of esophageal atresia(common type)who underwent thoracotomy for repair. Exclusion criteria: any risk factor that affect surgical result, like low birth weight(under2kg). severe pulmonary infection, major cardiopulmonary problems, long gap atresia; any untoward problems unrelated to surgical technique that can affect surgical results.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
N/A
Randomization description
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
kermanshah university of medical sciences
Street address
shahid beheshti av.-research center of university
City
kermanshah
Postal code
6714869914714869914
Approval date
2012-11-20, 1391/08/30
Ethics committee reference number
/7/420/پ
2
Ethics committee
Name of ethics committee
kermanshah university of medical sciences
Street address
shahi beheshthi street. research center
City
kermanshah
Postal code
6714869914714869914
Approval date
2012-11-20, 1391/08/30
Ethics committee reference number
/7/420/پ
Health conditions studied
1
Description of health condition studied
Esophageal atresia with tracheoesophagalfistula. fistula
ICD-10 code
Q39-1
ICD-10 code description
Atresia of oesophagus with tracheo-oesophageal fistula
Primary outcomes
1
Description
Mortality
Timepoint
1 month
Method of measurement
Counting of mortality cases
Secondary outcomes
1
Description
Increase of survival
Timepoint
1 month
Method of measurement
Counting of survived cases
Intervention groups
1
Description
Surgery has been done extrapleural in study group (esophagus exposed without entrance to pleural space.
Category
Treatment - Surgery
2
Description
Surgery is intrapleural and esophagus exposes by entrance to pleural space in control group.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohammad Kermanshahi hospital
Full name of responsible person
Dr. Omid Amanollahi
Street address
Mohammad Kermanshahi hospital, Helal Ahmar cross
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Research center- Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Omid Amanollahi
Position
Assistant professor of pediatric surgery
Other areas of specialty/work
Street address
Mohamad Kermanshahi Hospital
City
Kermanshah
Postal code
Phone
+98 83 1721 8206
Fax
Email
oamanollahi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Omid Amanollahi
Position
Assistant professor of pediatric surgery
Other areas of specialty/work
Street address
Mohammad Kermanshahi hospital
City
Kermanshah
Postal code
Phone
+98 83 1721 8206
Fax
Email
oamanollahi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Omid Amanollahi
Position
Assistant professor of pediatric surgery
Other areas of specialty/work
Street address
Mohammad Kermanshahi Hospital
City
Kermanshah
Postal code
Phone
+98 83 1721 8206
Fax
Email
oamanollahi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)