Azygos Vein Preservation; Its Impact on Early Outcomes After Neonatal EA/TOF Repair
Condition: Azygos Vein Preservation Versus Disconnection; Tracheo-Esophageal Fistula With Atresia of Esophagus; Leak, Anastomotic; Stricture Esophagus; Pneumonitis; Postoperative
MeSH terms: Pneumonia; Esophageal Atresia; Esophageal Fistula; Tracheoesophageal Fistula; Fistula; Anastomotic Leak
Study type: Interventional

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

Detailed description: 
      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.
    

Intervention name(s): EA/TOF primary repair with Azygos vein preservation; EA/TOF primary repair with Azygos vein sacrifice (disconnection)
Intervention type(s): Procedure; Procedure
Intervention description(s): 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); 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)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant)
Primary purpose: Treatment
Keywords: Esophageal Atresia,; Tracheoesophageal fistula,; Preservation of the Azygos vein,; Division of Azygos vein,; Pediatrics