Active — Not RecruitingNot Applicable

Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair

United States142 participantsStarted 2018-05-11

Plain-language 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.

Who can participate

Age range6 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Infants diagnosed with type C esophageal atresia: proximal esophageal atresia and distal tracheoesophageal fistula * Primary repair of the esophageal atresia within the first six months of life * Minimum follow up of 1 year (12 months) Exclusion Criteria: * Other types of esophageal atresia without esophageal anastomosis creation * Major anomaly that influences likelihood of developing primary outcome or affects surgical treatment considerations

What they're measuring

Anastomotic stricture

Timeframe: 12 months

Trial details

NCT IDNCT03730454

SponsorPhoenix Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-28

View on ClinicalTrials.gov More Esophageal Atresia trials