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Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair
Sponsor: Phoenix Children's Hospital
Summary
This trial will compare the effectiveness of two common surgical practices for Type C esophageal atresia repair: esophageal atresia (EA) with distal tracheoesophageal fistula (TEF). Infants with EA/TEF requiring surgical intervention will be recruited. Subjects will be randomized to either repair with or without transanstomotic tube (TT) during esophageal anastomosis creation. Primary outcome is symptomatic anastomotic stricture development requiring dilation within 12 months.
Official title: A Multi-Center Randomized Trial of Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair
Key Details
Gender
All
Age Range
Any - 6 Months
Study Type
INTERVENTIONAL
Enrollment
142
Start Date
2018-05-11
Completion Date
2026-02-28
Last Updated
2025-03-10
Healthy Volunteers
No
Interventions
Transanastomotic Tube (5FR)
5FR tube left in place for 5 days after completion of esophageal anastomosis.
No Transanastomotic Tube
No transanastomotic tube used during repair
Locations (10)
Phoenix Children's Hospital
Phoenix, Arizona, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Rady Children's Hospital
San Diego, California, United States
Benioff Children's Hospital
San Francisco, California, United States
Lucile Packard Children's Hospital
Stanford, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Doernbecher Children's Hospital
Portland, Oregon, United States
Children's Medical Center
Dallas, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States