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

IF 2.4 2区医学 Q1 PEDIATRICS

Journal of pediatric surgery Pub Date : 2024-09-28 DOI:10.1016/j.jpedsurg.2024.161970

Ramyasree Bade , Nitin James Peters , Shivani Dogra , Muneer Abas Malik , Jai Kumar Mahajan , Sandhya Yaddanapudi , Shailesh Solanki , Monika Bawa , Ram Samujh

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引用次数: 0

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).

查看原文本刊更多论文

使用或不使用经吻合器管道修复 C 型气管食管瘘/食管闭锁：一项试点随机对照试验。

背景：在食管闭锁/气管食管瘘（EA/TEF）修复过程中使用经吻合口喂食管（TAFT）的目的是通过早期喂食、减少肠外营养的需求以及通过吻合口支架减少吻合口漏等并发症来提高疗效。然而，由于各种报道相互矛盾，人们对 TAFT 的利弊还存在争议。因此，我们进行了一项前瞻性随机对照试验，以阐明 TAFT 对术后结果的影响以及避免 TAFT 的潜在益处：我们进行了一项单中心随机对照试验，对象是在 2022 年 1 月至 2023 年 6 月期间接受手术的 53 名确诊为 C 型 EA/TEF 的新生儿。患者被随机分为TAFT组（30人）和非TAFT组（23人）。患者出院后接受至少 6 个月的随访。研究的主要目的是比较两组患者在 EA/TEF 初级修复术后的吻合口漏率。次要目标包括术后早期结果，如吻合口狭窄的发生率、开始进食所需的时间、达到完全进食所需的时间、短暂缓解的不明原因事件（BRUE）或急性危及生命事件（ALTE）的发生率、胃食管反流（GER）的发生率、体格生长以及术后30天内的全因死亡率：研究结果表明，TAFT 置入与吻合口漏发生率较高（20% 对 0，P = 0.03）有关。不过，两组患者的 30 天死亡率并无差异。虽然 TAFT 组的吻合口狭窄率和胃食管反流率更高（54.5% 对 27.8%，p = 0.08；25% 对 57.1%，p = 0.076），但没有统计学意义。避免TAFT可提前开始肠内喂养（18天 vs 22天，p = 0.002），缩短实现完全喂养的时间（15天 vs 21天，p = 0.03），缩短TPN持续时间（3天 vs 10天；p = 0.001），改善2周随访时的体重增加（27.5克/公斤/天 vs 24.4克/公斤/天，p值 = 0.037），减少6个月时ALTE/BRUE的发生率（11.1% vs 48%，p = 0.01）：尽管之前的研究已涉及 TAFT 对吻合口漏、狭窄、TPN 使用和肠道喂养等并发症的影响，但前瞻性随机研究仍然有限，而且对胃食管反流、体格生长和 ALTE/BRUE 发生率的影响仍有待探索。本研究评估了在资源匮乏的环境中 EA/TEF 的短期疗效，揭示了不使用 TAFT 进行修复的潜在益处，如降低吻合口漏发生率、提早进食、减少胃食管反流、改善体格生长和降低 ALTE/BRUE 发生率：证据等级：II 级（治疗研究/随机对照试验）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of pediatric surgery 医学-外科

CiteScore

1.10

自引率

12.50%

发文量

569

审稿时长

38 days

期刊介绍： The journal presents original contributions as well as a complete international abstracts section and other special departments to provide the most current source of information and references in pediatric surgery. The journal is based on the need to improve the surgical care of infants and children, not only through advances in physiology, pathology and surgical techniques, but also by attention to the unique emotional and physical needs of the young patient.