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OpenTrials
Completed

NCT Number: NCT05957562

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.

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Key information

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EA/TOF primary repair with Azygos vein preservation

Procedure

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)

Procedure

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 outcomes

  1. gap between the pouches after mobilization

    Time frame: 2 years

    missed distance between the mobilized esophageal pouches in centimeters

  2. operative time

    Time frame: 2 years

    operative time in minutes

  3. early postoperative pneumonia

    Time frame: 35 months

    postoperative pneumonitis in number

  4. early postoperative anastomotic leak

    Time frame: 35 months

    anastomotic leakage rate in number

  5. early postoperative anastomotic stricture

    Time frame: 35 months

    anastomotic stricture rate in number

  6. mortality

    Time frame: 35 months

    mortality rate in number

Secondary outcomes

  1. gestational age

    Time frame: 2 years

    gestational age in weeks

  2. sex

    Time frame: 2 years

    patient's gender in number

  3. associated congenital anomalies

    Time frame: 2 years

    associated congenital anomalies in number

  4. associated anomalies

    Time frame: 2 years

    associated congenital anomalies in percentage of cases

Other outcomes

  1. Spitz classification

    Time frame: 2 years

    Spitz classification of mortality risk of TOF/EA in number

Sponsors and collaborators

Lead sponsor

dr. Muhammad Abdelhafez Mahmoud, MD

Other

Registry information

Official study title

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

Acronym: EArAzygousvp

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jul 24, 2023
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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