Nationwide Children's Hospital, 700 Children's Drive, Columbus, OH, USA.
Nationwide Children's Hospital, 700 Children's Drive, Columbus, OH, USA.
J Pediatr Surg. 2021 Aug;56(8):1449-1453. doi: 10.1016/j.jpedsurg.2021.04.022. Epub 2021 Apr 30.
For the past four decades, routine daily postoperative anal dilation by parents has been the standard treatment following a primary posterior sagittal anorectoplasty (PSARP). However, the clinical benefit of this practice has never been formally investigated. It is known that dilations can have a significant negative psychological impact on patients and families, and therefore, we aimed to study if routine dilations after a PSARP are necessary.
A prospective, single institution randomized controlled clinical trial was conducted on patients with anorectal malformations (ARM) at our institution between 2017 and 2019. Patients were randomized to either a dilation or non-dilation group following their PSARP. Inclusion criteria included age less than 24 months and all patients undergoing primary repair of their ARM (except for cloaca). Patient characteristics, type of ARM, presence of colostomy, postoperative stricture, need for a skin level revision (Heineke-Mikulicz anoplasty (HMA)), and need for redo PSARP were recorded. The primary outcome of the trial was stricture formation. The secondary outcome included strictures requiring interventions. A p-value of less than 0.05 was considered statistically significant. Institutional approval was obtained for this study and informed consents were obtained from all the patients.
49 patients were included in our study. 5 (21%) in the dilation group and 8 (32%) in the non-dilation group developed strictures (p=0.21). Of these, 3 (13%) patients in the dilation group required HMA, and 4 (16%) patients in the non-dilation group required HMA (p=0.72). 4 patients required a redo operation for strictures: 2 in the dilation arm (these patients despite the plan to do dilations, chose not to do them consistently) and 2 in the non-dilation arm (p=0.59).
Routine dilations after PSARP do not significantly reduce stricture formation. Based on these results, non-dilation is a viable alternative, and HM anoplasty remains a good back-up plan if a stricture develops.
Level I.
在过去的四十年中，父母在术后每天例行对肛门进行扩张一直是原发性后路矢状入路肛门直肠成形术（PSARP）后的标准治疗方法。然而，这种治疗方法的临床益处从未经过正式研究。众所周知，扩张术会对患者和家庭产生重大的负面影响，因此，我们旨在研究 PSARP 后常规扩张是否必要。
我们于 2017 年至 2019 年在机构内对肛门直肠畸形（ARM）患者进行了一项前瞻性、单机构随机对照临床试验。患者在 PSARP 后随机分为扩张组或非扩张组。纳入标准包括年龄小于 24 个月，所有患者均接受 ARM 一期修复（除 Cloaca 外）。记录患者特征、ARM 类型、是否存在结肠造口术、术后狭窄、是否需要皮肤水平修正（Heineke-Mikulicz 成形术（HMA））以及是否需要重新进行 PSARP。试验的主要结局是狭窄形成。次要结局包括需要干预的狭窄。p 值小于 0.05 被认为具有统计学意义。本研究获得机构批准，并获得所有患者的知情同意。
我们的研究共纳入 49 例患者。扩张组有 5 例（21%）和非扩张组有 8 例（32%）发生狭窄（p=0.21）。其中，扩张组有 3 例（13%）患者需要进行 HMA，非扩张组有 4 例（16%）患者需要进行 HMA（p=0.72）。4 例患者因狭窄需要再次手术：扩张组 2 例（尽管计划进行扩张，但这 2 例患者并未持续进行），非扩张组 2 例（p=0.59）。
PSARP 后常规扩张并不能显著降低狭窄形成的风险。基于这些结果，不进行扩张是一种可行的替代方法，如果发生狭窄，HMA 仍是一种良好的后备方案。
I 级。
