An interventional study of EA/TOF primary repair with Azygos vein preservation and EA/TOF primary repair with Azygos vein sacrifice (disconnection) in Azygos Vein Preservation Versus Disconnection, Tracheo-Esophageal Fistula With Atresia of Esophagus and Leak, Anastomotic, sponsored by dr. Muhammad Abdelhafez Mahmoud, MD. Completed at 1 site in Egypt. Open to participants aged 1 Day to 28 Days. Per ClinicalTrials.gov, last updated 2023-07-24.
Sponsored by dr. Muhammad Abdelhafez Mahmoud, MD · Not applicable, Interventional, and Treatment
Azygos vein preservation revisited: impact on early outcomes after repair of Esophageal atresia/ Tracheo-Esophageal Fistula in newborns. A randomized controlled study.
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.
Exclusion Criteria:
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
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)
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)
gap between the pouches after mobilization
missed distance between the mobilized esophageal pouches in centimeters
Time frame: 2 years
operative time
operative time in minutes
Time frame: 2 years
early postoperative pneumonia
postoperative pneumonitis in number
Time frame: 35 months
early postoperative anastomotic leak
anastomotic leakage rate in number
Time frame: 35 months
early postoperative anastomotic stricture
anastomotic stricture rate in number
Time frame: 35 months
mortality
mortality rate in number
Time frame: 35 months
gestational age
gestational age in weeks
Time frame: 2 years
sex
patient's gender in number
Time frame: 2 years
associated congenital anomalies
associated congenital anomalies in number
Time frame: 2 years
associated anomalies
associated congenital anomalies in percentage of cases
Time frame: 2 years
Spitz classification
Spitz classification of mortality risk of TOF/EA in number
Time frame: 2 years
Plan to share: No — The datasets used and/or analyzed during the current study are available from the corresponding author but could not be sent owing to the medicolegal aspect of the hospital policy.
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dr. Muhammad Abdelhafez Mahmoud, MD