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

NCT ID: NCT05957562

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-10
• Study Completion Date: 2023-04-09

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

EA/TOF primary repair with Azygos vein preservation

Intervention Type: 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)

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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)

Interventions

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)

Intervention Type: 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)

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

dr. Muhammad Abdelhafez Mahmoud, MD

OTHER

Sponsor Role: lead

Responsible Party

dr. Muhammad Abdelhafez Mahmoud, MD

Lecturer of pediatric surgery, Al-Azhar Faculty of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ahmed Elshamy, MD

Role: STUDY_CHAIR

Pediatric Surgery Unit-Department of Surgery, Al-Azhar University, Assuit, Egypt

Locations

Pediatric Surgery Department, Al-Azhar University

Cairo, , Egypt

Countries

Egypt

Study Documents

Document Type: Study Protocol

View Document

Other Identifiers

AlAzharEArepairAzygouspreserve

Identifier Type: -

Identifier Source: org_study_id