search
Back to results

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

Primary Purpose

Azygos Vein Preservation Versus Disconnection, Tracheo-Esophageal Fistula With Atresia of Esophagus, Leak, Anastomotic

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
EA/TOF primary repair with Azygos vein preservation
EA/TOF primary repair with Azygos vein sacrifice (disconnection)
Sponsored by
dr. Muhammad Abdelhafez Mahmoud, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Azygos Vein Preservation Versus Disconnection focused on measuring Esophageal Atresia,, Tracheoesophageal fistula,, Preservation of the Azygos vein,, Division of Azygos vein,, Pediatrics

Eligibility Criteria

1 Day - 28 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pediatric Surgery Department, Al-Azhar University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

EA/TOF primary repair with Azygos vein preservation

EA/TOF primary repair with Azygos vein sacrifice (disconnection)

Arm Description

primary esophagoesophagostomy with azygous vein preservation technique and will be done for 32 neonates with EA/TOF amenable for primary repair

primary esophagoesophagostomy with azygous vein disconnection ordinary technique and will be done for 32 neonates with EA/TOF suitable for primary repair

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 9, 2023
Last Updated
July 14, 2023
Sponsor
dr. Muhammad Abdelhafez Mahmoud, MD
search

1. Study Identification

Unique Protocol Identification Number
NCT05957562
Brief Title
Azygos Vein Preservation; Its Impact on Early Outcomes After Neonatal EA/TOF Repair
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 10, 2020 (Actual)
Primary Completion Date
October 6, 2022 (Actual)
Study Completion Date
April 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
dr. Muhammad Abdelhafez Mahmoud, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Azygos Vein Preservation Versus Disconnection, Tracheo-Esophageal Fistula With Atresia of Esophagus, Leak, Anastomotic, Stricture Esophagus, Pneumonitis; Postoperative
Keywords
Esophageal Atresia,, Tracheoesophageal fistula,, Preservation of the Azygos vein,, Division of Azygos vein,, Pediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 patients
Masking
Participant
Masking Description
single (participants will choose from sealed closed envelopes)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EA/TOF primary repair with Azygos vein preservation
Arm Type
Active Comparator
Arm Description
primary esophagoesophagostomy with azygous vein preservation technique and will be done for 32 neonates with EA/TOF amenable for primary repair
Arm Title
EA/TOF primary repair with Azygos vein sacrifice (disconnection)
Arm Type
Active Comparator
Arm Description
primary esophagoesophagostomy with azygous vein disconnection ordinary technique and will be done for 32 neonates with EA/TOF suitable for primary repair
Intervention Type
Procedure
Intervention Name(s)
EA/TOF primary repair with Azygos vein preservation
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
EA/TOF primary repair with Azygos vein sacrifice (disconnection)
Intervention Description
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 Outcome Measure Information:
Title
gap between the pouches after mobilization
Description
missed distance between the mobilized esophageal pouches in centimeters
Time Frame
2 years
Title
operative time
Description
operative time in minutes
Time Frame
2 years
Title
early postoperative pneumonia
Description
postoperative pneumonitis in number
Time Frame
35 months
Title
early postoperative anastomotic leak
Description
anastomotic leakage rate in number
Time Frame
35 months
Title
early postoperative anastomotic stricture
Description
anastomotic stricture rate in number
Time Frame
35 months
Title
mortality
Description
mortality rate in number
Time Frame
35 months
Secondary Outcome Measure Information:
Title
gestational age
Description
gestational age in weeks
Time Frame
2 years
Title
sex
Description
patient's gender in number
Time Frame
2 years
Title
associated congenital anomalies
Description
associated congenital anomalies in number
Time Frame
2 years
Title
associated anomalies
Description
associated congenital anomalies in percentage of cases
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Spitz classification
Description
Spitz classification of mortality risk of TOF/EA in number
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Elshamy, MD
Organizational Affiliation
Pediatric Surgery Unit-Department of Surgery, Al-Azhar University, Assuit, Egypt
Official's Role
Study Chair
Facility Information:
Facility Name
Pediatric Surgery Department, Al-Azhar University
City
Cairo
ZIP/Postal Code
11651
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://orcid.org/0000-0003-0558-6402
Available IPD/Information Identifier
orcid.org/0000-0003-0558-6402

Learn more about this trial

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

We'll reach out to this number within 24 hrs