Comparison of Modified Pleural Flap Technique vs. Standard Anastomosis for Congenital Tracheo- Esophageal Fistula Repair: A Randomized Control Trial

Abstract

Background: Tracheoesophageal fistula (TEF) with or without esophageal atresia (EA) is a challenging congenital condition necessitating surgical intervention. The advent of various surgical techniques has sought to improve outcomes and reduce postoperative complications such as anastomotic leakage and stricture formation, which significantly impact neonatal morbidity and mortality. Objective: The aim of this randomized controlled trial was to compare the efficacy of the modified pleural flap technique against the conventional anastomosis technique in the surgical repair of TEF. Methods: Conducted at the Children’s Hospital and Institute of Child Health in Lahore, this study involved 44 full-term neonates, diagnosed with TEF, and weighing over 2 kg. Subjects were randomized into two groups: one receiving the conventional anastomosis (Group A) and the other undergoing the modified pleural flap technique (Group B). Preoperative characteristics, intraoperative details, and postoperative outcomes were meticulously recorded. Statistical analysis was performed using SPSS version 25.0, focusing on the incidence of anastomotic leakage, stricture formation, length of hospital stay, and mortality within 30 days post-surgery. Results: Group B patients experienced significantly lower rates of anastomotic leakage by the 5th postoperative day (9.1%) and 14th postoperative day (13.6%) compared to Group A (36.4% and 40.9%, respectively) with p-values of 0.031 and 0.042. Postoperative stricture formation was also less in Group B (9.1%) compared to Group A (36.4%), with a p-value of 0.031. The mean hospital stay was longer for Group B (27.45 days) compared to Group A (22.09 days), and the mortality rate was lower in Group B, although not statistically significant (p-value = 0.148). Conclusion: The modified pleural flap technique in TEF repair demonstrates a significant reduction in early postoperative complications, offering a promising improvement over the conventional approach. Despite a longer hospital stay, the enhanced outcomes highlight its potential for becoming the preferred surgical intervention for TEF.