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

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

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

Study Overview

• Status: Completed
• Conditions: Leak, Anastomotic; Tracheo-Esophageal Fistula With Atresia of Esophagus; Azygos Vein Preservation Versus Disconnection; Stricture Esophagus; Pneumonitis; Postoperative
• Intervention / Treatment: Procedure: EA/TOF primary repair with Azygos vein preservation; Procedure: EA/TOF primary repair with Azygos vein sacrifice (disconnection)

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11651
    • Pediatric Surgery Department, Al-Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EA/TOF primary repair with Azygos vein preservation; 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 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)
Active Comparator: EA/TOF primary repair with Azygos vein sacrifice (disconnection); 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gap between the pouches after mobilization	missed distance between the mobilized esophageal pouches in centimeters	2 years
operative time	operative time in minutes	2 years
early postoperative pneumonia	postoperative pneumonitis in number	35 months
early postoperative anastomotic leak	anastomotic leakage rate in number	35 months
early postoperative anastomotic stricture	anastomotic stricture rate in number	35 months
mortality	mortality rate in number	35 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gestational age	gestational age in weeks	2 years
sex	patient's gender in number	2 years
associated congenital anomalies	associated congenital anomalies in number	2 years
associated anomalies	associated congenital anomalies in percentage of cases	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spitz classification	Spitz classification of mortality risk of TOF/EA in number	2 years

Collaborators and Investigators

• Sponsor: dr. Muhammad Abdelhafez Mahmoud, MD
• Investigators: Study Chair: Ahmed Elshamy, MD, Pediatric Surgery Unit-Department of Surgery, Al-Azhar University, Assuit, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2020
• Primary Completion (Actual): October 6, 2022
• Study Completion (Actual): April 9, 2023

Study Registration Dates

• First Submitted: July 9, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Estimated): July 24, 2023

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Pediatrics; Esophageal Atresia,; Tracheoesophageal fistula,; Preservation of the Azygos vein,; Division of Azygos vein,
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Postoperative Complications; Congenital Abnormalities; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Esophageal Diseases; Digestive System Fistula; Digestive System Abnormalities; Tracheal Diseases; Respiratory Tract Fistula; Pneumonia; Fistula; Anastomotic Leak; Esophageal Atresia; Tracheoesophageal Fistula; Esophageal Fistula
• Other Study ID Numbers: AlAzharEArepairAzygouspreserve

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Study Data/Documents

1. Study Protocol
   Information identifier: orcid.org/0000-0003-0558-6402

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No