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

NCT05957562 | Completed

• 1 other identifier: AlAzharEArepairAzygouspreserve
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Esophageal Atresia,; Tracheoesophageal fistula,; Preservation of the Azygos vein,; Division of Azygos vein,; Pediatrics

Outcome Measures

Primary Outcomes (6)

• gap between the pouches after mobilization

  missed distance between the mobilized esophageal pouches in centimeters

  2 years

• operative time

  operative time in minutes

  2 years

• early postoperative pneumonia

  postoperative pneumonitis in number

  35 months

• early postoperative anastomotic leak

  anastomotic leakage rate in number

  35 months

• early postoperative anastomotic stricture

  anastomotic stricture rate in number

  35 months

• mortality

  mortality rate in number

  35 months

Secondary Outcomes (4)

• gestational age

  2 years

• sex

  2 years

• associated congenital anomalies

  2 years

• associated anomalies

  2 years

Other Outcomes (1)

• Spitz classification

  2 years

Study Arms (2)

EA/TOF primary repair with Azygos vein preservation

ACTIVE COMPARATOR

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

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

ACTIVE COMPARATOR

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)

Interventions

EA/TOF primary repair with Azygos vein preservation 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 preservation

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

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• all neonates suitable for primary repair of Esophageal Atresia and tracheoesophageal fistula

You may not qualify if:

• long gap esophageal atresia (\> 3 cm)
• esophageal atresia without tracheoesophageal fistula

Sponsors & Collaborators

• dr. Muhammad Abdelhafez Mahmoud, MD: lead

Study Sites (1)

Pediatric Surgery Department, Al-Azhar University

Cairo, 11651, Egypt

Location

MeSH Terms

Conditions

Esophageal atresia with or without tracheoesophageal fistula; Anastomotic Leak; Esophageal Stenosis; Pneumonia; Esophageal Atresia; Tracheoesophageal Fistula

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Esophageal Fistula; Digestive System Fistula; Respiratory Tract Fistula; Tracheal Diseases; Fistula; Pathological Conditions, Anatomical

Study Officials

• Ahmed Elshamy, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single (participants will choose from sealed closed envelopes)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of pediatric surgery, Al-Azhar Faculty of Medicine

Model Details: 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

Study Record Dates

• First Submitted: July 9, 2023
• First Posted: July 24, 2023
• Study Start: April 10, 2020
• Primary Completion: October 6, 2022
• Study Completion: April 9, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)