The aim of this study was to evaluate the effectiveness of Azygos vein occlusion in patients with Tracheoesophageal fistula and Esophageal atresia.
Design
Clinical trial with control group and a parallel group without blind strain randomized on 40 patients. For randomization, 4-way permutation block method was used.
Settings and conduct
This was a clinical trial conducted on neonates with esophageal atresia and Tracheoesophageal fistula in Imam Khomeini Hospital in Ahvaz.
Participants/Inclusion and exclusion criteria
Neonates with Tracheoesophageal fistula and Esophageal atresia
Intervention groups
1.Tracheoesophageal fistula and Esophageal atresia repair with occlusion of the azygos vein.
2.Tracheoesophageal fistula and Esophageal atresia repair with preservation of the azygos vein.
Main outcome variables
At the beginning of the study, age, gender, weight, anomalies associated with Esophageal atresia of all neonates were recorded, then, all neonates were randomly divided into two equal groups. In one group, Esophageal atresia is repaired with azygos vein ligate and in the other group Esophageal atresia repaired with azygos vein preservation. In this study, duration of surgery, rate of pneumonia, existence of anastomosis leak, stenosis at the site of anastomosis and mortality rate between the two groups of neonates were investigated.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201012049012N1
Registration date:2020-11-20, 1399/08/30
Registration timing:retrospective
Last update:2020-11-20, 1399/08/30
Update count:0
Registration date
2020-11-20, 1399/08/30
Registrant information
Name
behruz shayestezadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 3238
Email address
behruz.shayestezadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-24, 1398/02/04
Expected recruitment end date
2019-08-26, 1398/06/04
Actual recruitment start date
2019-04-24, 1398/02/04
Actual recruitment end date
2019-08-26, 1398/06/04
Trial completion date
2019-08-26, 1398/06/04
Scientific title
Evaluation of Azygos vein preservation Necessary in Primary Repair of Trachea esophageal Fistula with Esophageal Atresia
Public title
Azygos vein in Esophageal Atresia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
neonates with Trachea esophageal Fistula with Esophageal Atresia
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Neonates with a diagnosis of tracheoesophageal fistula with esophageal atresia who matched our diagnostic criteria will be selected to participate in the study. There will be randomly subdivided them in to Two group ' first whom which their Esophageal atresia will get treated with closure of azygous vein ' second whom which their Esophageal atresia will get treated with preserving the azygos vein. randomization will be simple and individual.
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 jondishapur university of medical sciences
Street address
Jundishapur university of medical sciences, golestan street, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-04-21, 1397/02/01
Ethics committee reference number
IR.AJUMS.REC.1397.011
Health conditions studied
1
Description of health condition studied
Tracheoesophageal fistula with Esophageal atresia
ICD-10 code
Q39.1
ICD-10 code description
Tracheoesophageal fistula with Esophageal atresia
Primary outcomes
1
Description
Pneumonia
Timepoint
Evidence of pneumonia was investigated before surgery one week and one month after surgery.
Method of measurement
Clinical examination and laboratory evidence.
2
Description
Anastomosis leak
Timepoint
Daily after surgery until the patient's PO tolerance and discharge
Method of measurement
Clinical examinations and laboratory evidence
3
Description
duration of surgery
Timepoint
Based on hours after surgery
Method of measurement
Based on hours after surgery
4
Description
Stenosis of the place of anastomosis
Timepoint
After patient po
Method of measurement
by radiography and clinical examination
5
Description
Blood transfusion rate
Timepoint
From surgery to patient discharge
Method of measurement
by pack cell transfusion rate
6
Description
length of hospital stay
Timepoint
From surgery to patient discharge
Method of measurement
based on days of stay
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Neonates which Esophageal atresia and Tracheoesophageal fistula repaired with azygos vein ligation.
Category
Treatment - Surgery
2
Description
Intervention group: Neonates which Esophageal atresia and Tracheoesophageal fistula repaired with preserving the Azygos vein.