Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05957562
Acronym
EArAzygousvp
Enrollment
64
Registered
2023-07-24
Start date
2020-04-10
Completion date
2023-04-09
Last updated
2023-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Esophageal Atresia,, Tracheoesophageal fistula,, Preservation of the Azygos vein,, Division of Azygos vein,, Pediatrics

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.

Interventions

PROCEDUREEA/TOF primary repair with Azygos vein preservation

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)

PROCEDUREEA/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)

Sponsors

dr. Muhammad Abdelhafez Mahmoud, MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

single (participants will choose from sealed closed envelopes)

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

Eligibility

Sex/Gender
ALL
Age
1 Days to 28 Days
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

Design outcomes

Primary

MeasureTime frameDescription
mortality35 monthsmortality rate in number
gap between the pouches after mobilization2 yearsmissed distance between the mobilized esophageal pouches in centimeters
operative time2 yearsoperative time in minutes
early postoperative pneumonia35 monthspostoperative pneumonitis in number
early postoperative anastomotic leak35 monthsanastomotic leakage rate in number
early postoperative anastomotic stricture35 monthsanastomotic stricture rate in number

Secondary

MeasureTime frameDescription
gestational age2 yearsgestational age in weeks
sex2 yearspatient's gender in number
associated congenital anomalies2 yearsassociated congenital anomalies in number
associated anomalies2 yearsassociated congenital anomalies in percentage of cases

Other

MeasureTime frameDescription
Spitz classification2 yearsSpitz classification of mortality risk of TOF/EA in number

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026