Azygos Vein Preservation Revisited: Impact on Early Outcomes After Repair of Esophageal Atresia/ Tracheo-Esophageal Fistula in Newborns: A Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 64
- Locations
- 2
- Primary Endpoint
- gap between the pouches after mobilization
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
single (participants will choose from sealed closed envelopes)
Eligibility Criteria
- Ages
- 1 Day to 28 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
gap between the pouches after mobilization
Time Frame: 2 years
missed distance between the mobilized esophageal pouches in centimeters
mortality
Time Frame: 35 months
mortality rate in number
early postoperative pneumonia
Time Frame: 35 months
postoperative pneumonitis in number
operative time
Time Frame: 2 years
operative time in minutes
early postoperative anastomotic leak
Time Frame: 35 months
anastomotic leakage rate in number
early postoperative anastomotic stricture
Time Frame: 35 months
anastomotic stricture rate in number
Secondary Outcomes
- sex(2 years)
- associated congenital anomalies(2 years)
- gestational age(2 years)
- associated anomalies(2 years)
Investigators
dr. Muhammad Abdelhafez Mahmoud, MD
Lecturer of pediatric surgery, Al-Azhar Faculty of Medicine
Al-Azhar University