Azygos Vein Preservation; Its Impact on Early Outcomes After Neonatal EA/TOF Repair

Study Overview
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Brief Summary
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Azygos vein preservation revisited: impact on early outcomes after repair of Esophageal atresia/ Tracheo-Esophageal Fistula in newborns. A randomized controlled study.

Detailed Description
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Since the first successful repair of esophageal atresia/tracheoesophageal fistula was performed approximately eight decades ago, surgeons have made considerable technical advances in solving intraoperative surgical challenges and reducing postoperative complications. According to some surgeons, the advantage of maintaining the Azygos vein makes this modification attractive. This study aimed to explore the benefits of retaining the Azygos vein during surgery for Esophageal Atresia with tracheoesophageal fistula, to emphasize its advantages in terms of reducing anastomotic leak, stricture, and other postoperative outcomes. Patients and Methods: This prospective randomized study was conducted between April 2020 and April 2023. The study included all newborns with (EA & TEF) eligible for primary repair, patients were randomly assigned to either Group A or Group B. (Group A) patients who underwent Azygos vein preservation during TEF repair, whereas the remaining patients (Group B) had Azygos vein disconnection. Statistical analysis: The Statistical Package for Social Sciences (SPSS) (version 23.0, IBM Corp IBM Corp., Armonk, NY, USA) was used for statistical analysis. The chi-square test (X2) was used to compare qualitative data in the groups, while an independent-sample t-test was used to compare quantitative data between groups. The degree of confidence was set at 95%. The p-value was considered significant at a level of 0.05. Discussion: will focus on advantages of azygous vein preservation on intactness of esophageal anastomosis, retaining the venous drainage of the bronchial system, and chest wall. Points of discussion will include effects of Azygous vein preservation on incidence of postoperative pneumonitis, anastomotic leakage and stricture rate, and mortality rate. The results obtained from this study will be compared between both groups and with those reported in the literature. Finally, the investigators will conclude the reconstructive technique that gives the better results and least morbidity.

Official Title
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Azygos Vein Preservation Revisited: Impact on Early Outcomes After Repair of Esophageal Atresia/ Tracheo-Esophageal Fistula in Newborns: A Randomized Controlled Study

Conditions
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Azygos Vein Preservation Versus Disconnection, Tracheo-Esophageal Fistula With Atresia of Esophagus, Leak, Anastomotic, Stricture Esophagus, Pneumonitis; Postoperative

Intervention / Treatment
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* Procedure: EA/TOF primary repair with Azygos vein preservation
* Procedure: EA/TOF primary repair with Azygos vein sacrifice (disconnection)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all neonates suitable for primary repair of Esophageal Atresia and tracheoesophageal fistula Exclusion Criteria: long gap esophageal atresia (> 3 cm) esophageal atresia without tracheoesophageal fistula

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This randomized controlled study conducted to assess the technical feasibility and surgical outcomes of one stage surgical repair, either with Azygos vein preservation or with Azygous vein disconnection, in newborns diagnosed with Esophageal Atresia and tracheoesophageal fistula. It includes 64 neonates with TOF/EA who will be randomly divided (using the sealed closed envelope method) into two equal groups, each group will include 34 neonatal patients
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EA/TOF primary repair with Azygos vein preservation<br>primary esophagoesophagostomy with azygous vein preservation technique and will be done for 32 neonates with EA/TOF amenable for primary repair | Procedure: EA/TOF primary repair with Azygos vein preservation<br>* primary repair of EA/TOF with either azygous vein preservation or disconnection (to assess the effects and expected benefits of the former technique on viability of the repair and decrease of postoperative early complications and mortality rate)<br>|
| Active Comparator: EA/TOF primary repair with Azygos vein sacrifice (disconnection)<br>primary esophagoesophagostomy with azygous vein disconnection ordinary technique and will be done for 32 neonates with EA/TOF suitable for primary repair | Procedure: EA/TOF primary repair with Azygos vein sacrifice (disconnection)<br>* primary repair of EA/TOF with either azygous vein preservation or disconnection (to assess the effects and expected benefits of the former technique on viability of the repair and decrease of postoperative early complications and mortality rate)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gap between the pouches after mobilization | missed distance between the mobilized esophageal pouches in centimeters | 2 years | 
| operative time | operative time in minutes | 2 years | 
| early postoperative pneumonia | postoperative pneumonitis in number | 35 months | 
| early postoperative anastomotic leak | anastomotic leakage rate in number | 35 months | 
| early postoperative anastomotic stricture | anastomotic stricture rate in number | 35 months | 
| mortality | mortality rate in number | 35 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gestational age | gestational age in weeks | 2 years | 
| sex | patient's gender in number | 2 years | 
| associated congenital anomalies | associated congenital anomalies in number | 2 years | 
| associated anomalies | associated congenital anomalies in percentage of cases | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Atresia,, Tracheoesophageal fistula,, Preservation of the Azygos vein,, Division of Azygos vein,, Pediatrics