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

Leak, Anastomotic Clinical Trial

— EArAzygousvp  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05957562
• Other study ID #: AlAzharEArepairAzygouspreserve
• Status: Completed
• Phase: N/A
• Start date: April 10, 2020
• Est. completion date: April 9, 2023

Study information

• Verified date: July 2023
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 9, 2023
• Est. primary completion date: October 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Anastomotic Leak
• Esophageal Atresia
• Esophageal Fistula
• Fistula
• Leak, Anastomotic
• Pneumonia
• Tracheoesophageal Fistula

Intervention

Procedure:
• EA/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)
• 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)

Locations

Country	Name	City	State
Egypt	Pediatric Surgery Department, Al-Azhar University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
dr. Muhammad Abdelhafez Mahmoud, MD

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Spitz classification	Spitz classification of mortality risk of TOF/EA in number	2 years
Primary	gap between the pouches after mobilization	missed distance between the mobilized esophageal pouches in centimeters	2 years
Primary	operative time	operative time in minutes	2 years
Primary	early postoperative pneumonia	postoperative pneumonitis in number	35 months
Primary	early postoperative anastomotic leak	anastomotic leakage rate in number	35 months
Primary	early postoperative anastomotic stricture	anastomotic stricture rate in number	35 months
Primary	mortality	mortality rate in number	35 months
Secondary	gestational age	gestational age in weeks	2 years
Secondary	sex	patient's gender in number	2 years
Secondary	associated congenital anomalies	associated congenital anomalies in number	2 years
Secondary	associated anomalies	associated congenital anomalies in percentage of cases	2 years