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

Sponsor

dr. Muhammad Abdelhafez Mahmoud, MD (Other)

Overall Status

Completed

CT.gov ID

NCT05957562

Collaborator

(none)

Enrollment

Location

Arms

35.9

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Azygos Vein Preservation Versus Disconnection Tracheo-Esophageal Fistula With Atresia of Esophagus Leak, Anastomotic Stricture Esophagus Pneumonitis; Postoperative	Procedure: EA/TOF primary repair with Azygos vein preservation Procedure: EA/TOF primary repair with Azygos vein sacrifice (disconnection)	N/A

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

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 Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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 patientsThis 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

Masking:

Single (Participant)

Masking Description:

single (participants will choose from sealed closed envelopes)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 10, 2020

Actual Primary Completion Date :

Oct 6, 2022

Actual Study Completion Date :

Apr 9, 2023

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

gestational age [2 years]
gestational age in weeks
sex [2 years]
patient's gender in number
associated congenital anomalies [2 years]
associated congenital anomalies in number
associated anomalies [2 years]
associated congenital anomalies in percentage of cases