Transanastomotic Tube Use and Anastomotic Stricture: A Multicenter Prospective Randomized Trial in Neonates Undergoing Repair of Type C Esophageal Atresia with Distal Tracheoesophageal Fistula.

Abstract

Anastomotic stricture (AS) is the most common complication following repair of type C esophageal atresia with distal tracheoesophageal fistula (EA/TEF). Retrospective studies suggest transanastomotic tube (TT) use may increase AS risk but are limited by design. We conducted a multicenter randomized trial to evaluate the impact of TT placement on AS. Infants undergoing type C EA/TEF repair at 10 children's hospitals were randomized to TT placement or no TT. A total of 142 patients (74 no TT, 68 TT) were enrolled. The primary outcome was AS requiring dilation within 12 months. Secondary outcomes included anastomotic leak, feeding outcomes, and postoperative morbidity. Multivariable analysis adjusted for clinically relevant covariates. Baseline characteristics were similar between groups. No statistically significant difference in stricture rates was observed (47.3% no TT vs 53.7% TT; P=0.45). Rates of leak, infection, reoperation, and readmission were similar. On multivariable analysis adjusting for weight, thoracoscopic approach, anastomotic tension, leak, and acid suppression, TT use was not independently associated with stricture (OR 1.18, 95% CI 0.58-2.45; P=0.64). Moderate-to-severe surgeon-assessed anastomotic tension was the only independent predictor of stricture (OR 2.45, 95% CI 1.11-5.40; P=0.026). In this multicenter randomized trial, TT use was not associated with a statistically significant difference in AS risk. Anastomotic tension, as assessed intraoperatively by the surgeon, was the strongest predictor of stricture, underscoring the central role of surgical assessment in outcomes.