Repair of Type C Tracheo-esophageal Fistula/Esophageal Atresia With or Without Trans Anastomotic Tube: A Pilot Randomized Controlled Trial

Abstract

Background

The use of trans anastomotic feeding tube (TAFT) during the repair of Esophageal atresia/Tracheo-esophageal fistula (EA/TEF) aims to enhance outcomes by enabling early feeding, reducing the requirement for parenteral nutrition, and reducing complications such as anastomotic leak by stenting the anastomosis. However, TAFT's benefits and drawbacks are debated due to conflicting reports. Thus, we conducted a prospective pilot randomized control trial to elucidate the impact of TAFT on postoperative outcomes and the potential benefits of avoidance of TAFT.

Methods

We performed a single-center randomized controlled trial in 53 neonates diagnosed with Type C EA/TEF who were operated on from January 2022 to June 2023. The patients were randomized into TAFT (n = 30) and non-TAFT (n = 23) groups. The patients were followed up for a minimum of 6 months following discharge. The primary objective of the study was to compare the rate of anastomotic leaks following primary repair of EA/TEF in both groups. Secondary objectives included early postoperative outcomes such as the occurrence of anastomotic stricture, time taken to initiate feeding, the time required to reach full feeding, the incidence of brief resolved unexplained events (BRUE) or acute life-threatening events (ALTE), the incidence of gastroesophageal reflux (GER), somatic growth, and all-cause mortality within 30 days post-surgery.

Result

The study demonstrated that TAFT placement was associated with a higher incidence of anastomotic leaks (20 % vs 0, p = 0.03). However, there was no difference in the 30-day mortality between both groups. Although the rate of anastomotic strictures and GER was higher in the TAFT group (54.5 % vs 27.8 %, p = 0.08 and 25 % vs 57.1 %, p = 0.076), it did not reach statistical significance. Avoiding TAFT resulted in earlier initiation of enteral feeding (18 vs 22 days, p = 0.002), shorter time to achieve full feeds (15 vs 21 days, p = 0.03), reduced duration of TPN (3 vs 10 days; p = 0.001), improved weight gain at the 2-week follow-up (27.5 vs. 24.4 g/kg/day, p-value = 0.037) and lesser incidence of ALTE/BRUE (11.1 % vs 48 %, p = 0.01) at 6 months.

Conclusion

While previous research has covered TAFT's impact on complications such as anastomotic leak, stricture, use of TPN and enteral feed, prospective randomized studies remain limited, and the impact on GER, somatic growth, and occurrence of ALTE/BRUE is still unexplored. This study evaluated the short-term outcomes of EA/TEF in a resource-challenged setting, shedding light on the potential benefits of repair without TAFT such as reduction in the rate of anastomotic leak, earlier feeding, reduced GER, better somatic growth and reduced incidence of ALTE/BRUE.

Level of Evidence

Level II (Treatment study/Randomized controlled trial).