The purposeof this study is to Comparative survey of prevalence of postoperative complications in patients with esophageal atresia repaired withabsoarbable and nonabsorbale. This study is one Not Blinded clinica trial. 36person who afflicted esophagus Atresia and refer to Emam Reza and Mohammad Kermanshah hospital select in accessible sampling method and according to randomly table divide in two intervention groups in the first intervention group Anastomosis do with non absorbable Silk sutures and in the second intervention group Anastomosis do with absorbable Vikrel sutures , then two groups interventions patients first 48 hours,5 until 7 days and one year after surgery, would compare together in rate of Anastomosis Leakage, and one year after surgery in Stricture Anastomosis, mortality rate, average time that Stay in Hospital and Hospitalization Cost average. inclusion criteria: those who diagnosis afflicted to esophagus atresia according to radiology and clinical evidence and they are candidate for surgery .exclusion criteria: the space within towheaded of esophagus is more than 3 cm that has direct effect to prevalence of postoperative complications in Anastomosis place
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013101414333N11
Registration date:2013-10-26, 1392/08/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-10-26, 1392/08/04
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2012-11-21, 1391/09/01
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
Comparative survey of incidence of postoperative complications in patients with esophageal atresia repaired with absoarbable and nonabsorbale sutures
Public title
Comparative survey of incidence of postoperative complications in patients with esophageal atresia repaired with absoarbable and nonabsorbale sutures
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: those who diagnosised afflicted to Esophagus Atresia according to radiology and clinical evidence and they are candidate for surgery .exclusion criteria:the space within towheaded of Esophagus is more than 3 cm that has direct effect to prevalence of postoperative complications in Anastomose place
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
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
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2013-07-20, 1392/04/29
Ethics committee reference number
16065/پ/7/420
Health conditions studied
1
Description of health condition studied
Esophageal Atresia
ICD-10 code
Q39.1
ICD-10 code description
Atresia of oesophagus with tracheo-oesophageal fistula
Primary outcomes
1
Description
rate of Anastomosis Leakage
Timepoint
First 48 hours، 5-7 day after surgery
Method of measurement
Clinical And Radiology evidence
2
Description
Anastomosis Stricture
Timepoint
One year After Surgery
Method of measurement
Clinical And Radiology evidence
3
Description
Mortality Rate
Timepoint
One year After Surgery
Method of measurement
Patient Case
4
Description
Time average Stay in Hospital
Timepoint
One year After Surgery
Method of measurement
Patient case
5
Description
Hospitalization Cost Average
Timepoint
One year After Surgery
Method of measurement
patient case
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, Anastomosis do with non absorbable silk sutures
Category
Treatment - Surgery
2
Description
in the second intervention group, Anastomosis do with absorbable vicrel sutures
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. Mohamadreza Namdari
Street address
Emam Reza Hospital,Razi Boulvard,Sorkhleje
City
Kermanshah
2
Recruitment center
Name of recruitment center
Mohamad Kermanshahi Hospital
Full name of responsible person
Dr. Mohamadreza Namdari
Street address
Mohamad Kermanshahi Hospital,Chaharrah Helal Ahmar,Mosavari Street
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, 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
Vice Chancellor for Research Affairs, 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Omid Amanolahi
Position
Pediatric Surgeon
Other areas of specialty/work
Street address
Emam Reza Hospital,Razi Boulvard,Sorkhleje
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
oamanollahi@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)