Pediatric Surgery Department, Al-Azhar University
Cairo, 11651, Egypt
NCT Number: NCT05957562
Azygos vein preservation revisited: impact on early outcomes after repair of Esophageal atresia/ Tracheo-Esophageal Fistula in newborns. A randomized controlled study.
Looking for future studies?
Notify Me1 day–28 day
All sexes
Interventional
Not applicable
Cairo, 11651, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: 2 years
missed distance between the mobilized esophageal pouches in centimeters
Time frame: 2 years
operative time in minutes
Time frame: 35 months
postoperative pneumonitis in number
Time frame: 35 months
anastomotic leakage rate in number
Time frame: 35 months
anastomotic stricture rate in number
Time frame: 35 months
mortality rate in number
Time frame: 2 years
gestational age in weeks
Time frame: 2 years
patient's gender in number
Time frame: 2 years
associated congenital anomalies in number
Time frame: 2 years
associated congenital anomalies in percentage of cases
Time frame: 2 years
Spitz classification of mortality risk of TOF/EA in number
dr. Muhammad Abdelhafez Mahmoud, MD
Other
Azygos Vein Preservation Revisited: Impact on Early Outcomes After Repair of Esophageal Atresia/ Tracheo-Esophageal Fistula in Newborns: A Randomized Controlled Study
Acronym: EArAzygousvp
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.
Published trials that share one or more normalized conditions with this study.
NCT07100379
Congenital Abnormalities, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Boston, Massachusetts, United States
View Trial DetailsNCT07709923
Anastomotic Leak, Colonic Diseases
Foggia, Italy
View Trial DetailsNCT03148054
Anastomosis; Complications, Anastomotic Leak
Schlieren, Canton of Zurich, Switzerland
View Trial DetailsNCT05987787
Anastomotic Leak, Bariatric Surgery Candidate
Foggia, Italy
View Trial Details