Clinical trial NCT05957562: Azygos Vein Preservation; Its Impact on Early Outcomes After Neonatal EA/TOF Repair
Official title: Azygos Vein Preservation Revisited: Impact on Early Outcomes After Repair of Esophageal Atresia/ Tracheo-Esophageal Fistula in Newborns: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Azygos Vein Preservation Versus Disconnection
Tracheo-Esophageal Fistula With Atresia of Esophagus
Leak, Anastomotic
Stricture Esophagus
Pneumonitis; Postoperative
Keywords: Esophageal Atresia,
Tracheoesophageal fistula,
Preservation of the Azygos vein,
Division of Azygos vein,
Pediatrics
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 64
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: gap between the pouches after mobilization
timeFrame: 2 years
measure: operative time
timeFrame: 2 years
measure: early postoperative pneumonia
timeFrame: 35 months
measure: early postoperative anastomotic leak
timeFrame: 35 months
measure: early postoperative anastomotic stricture
timeFrame: 35 months
measure: mortality
timeFrame: 35 months
Secondary outcomes:
measure: gestational age
timeFrame: 2 years
measure: sex
timeFrame: 2 years
measure: associated congenital anomalies
timeFrame: 2 years
measure: associated anomalies
timeFrame: 2 years
Other outcomes:
measure: Spitz classification
timeFrame: 2 years
Locations:
city: Cairo
country: Egypt
facility: Pediatric Surgery Department, Al-Azhar University
Study officials:
affiliation: Pediatric Surgery Unit-Department of Surgery, Al-Azhar University, Assuit, Egypt
name: Ahmed Elshamy, MD
role: STUDY_CHAIR
References: