Sato Sumito, Oga Junichi, Shirahata Atsushi, Ishida Yasuo
Department of Gastroenterological and General Surgery, Showa University Fujigaoka Hospital, Yokohama, Japan.
Miyazaki Sorano Clinic, Miyazaki, Japan.
Quant Imaging Med Surg. 2023 Jan 1;13(1):441-448. doi: 10.21037/qims-22-471. Epub 2022 Nov 1.
Hemorrhoids are a common benign disorder that can require surgery for treatment. Aluminum potassium sulfate and tannic acid (ALTA) have been used as a sclerotherapy agent that induces noninvasive sclerosis and regression of hemorrhoids without surgery. However, there is no objective index for determining its effectiveness. In this study, we prospectively investigated the usefulness of our method as an objective indicator of the effectiveness of ALTA sclerotherapy.
From April 2015 to April 2019, 241 patients underwent ALTA sclerotherapy. We standardized a simple evaluation method using the lumen of the lower rectum as observed through a clear plastic proctoscope. Patients' hemorrhoids were evaluated preoperatively and their subjective satisfaction with treatment by our new method was evaluated on postoperative day 7.
Our method showed that among patients who lost the rectal lumen before treatment, the lumen was reacquired after ALTA sclerotherapy in 96.1% (224/233). McNemar test showed the effect of ALTA sclerotherapy to be significantly associated with lumen gain [κ value, 0.0027; 95% confidence interval (CI): 0.0001-0.0052], P<0.001]. Patients' subjective satisfaction with the treatment was significantly higher in the group reacquiring the lumen (Fisher's exact test, P=0.0186). Among those patients needing re-treatment, 59.4% (19/32) had lost their lumen during follow-up [mean difference, 0.578; standard deviation (SD): 0.502, P<0.001].
Our simple method using a clear plastic proctoscope could objectively indicate the effect of ALTA sclerotherapy and patients who needed re-treatment on losing their lumen during follow-up. We believe this method is highly advantageous for patients, can advocate the concept of the hemorrhoid shrinking sign, and will contribute to the development of new indication criteria for ALTA sclerotherapy.
痔疮是一种常见的良性疾病，可能需要手术治疗。硫酸铝钾和鞣酸（ALTA）已被用作一种硬化剂，可在不进行手术的情况下诱导痔疮发生非侵入性硬化和消退。然而，尚无确定其有效性的客观指标。在本研究中，我们前瞻性地研究了我们的方法作为ALTA硬化疗法有效性客观指标的实用性。
2015年4月至2019年4月，241例患者接受了ALTA硬化疗法。我们使用通过透明塑料直肠镜观察到的直肠下段管腔标准化了一种简单的评估方法。术前对患者的痔疮进行评估，并在术后第7天通过我们的新方法评估患者对治疗的主观满意度。
我们的方法显示，在治疗前失去直肠管腔的患者中，96.1%（224/233）在接受ALTA硬化疗法后重新获得了管腔。McNemar检验显示，ALTA硬化疗法的效果与管腔增加显著相关[κ值，0.0027；95%置信区间（CI）：0.0001 - 0.0052]，P<0.001]。重新获得管腔的组中患者对治疗的主观满意度显著更高（Fisher精确检验，P = 0.0186）。在那些需要再次治疗的患者中，59.4%（19/32）在随访期间失去了管腔[平均差异，0.578；标准差（SD）：0.502，P<0.001]。
我们使用透明塑料直肠镜的简单方法可以客观地表明ALTA硬化疗法的效果以及在随访期间失去管腔需要再次治疗的患者。我们认为这种方法对患者非常有利，可以倡导痔疮缩小征的概念，并将有助于制定ALTA硬化疗法的新适应证标准。
