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

NCT05957562 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-07-24

No results posted yet for this study

Summary

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

Conditions

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

Interventions

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)

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)

Sponsors & Collaborators

  • dr. Muhammad Abdelhafez Mahmoud, MD

    lead OTHER

Principal Investigators

  • Ahmed Elshamy, MD · Pediatric Surgery Unit-Department of Surgery, Al-Azhar University, Assuit, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-10
Primary Completion
2022-10-06
Completion
2023-04-09

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05957562 on ClinicalTrials.gov