Clinical impact of a new method using a clear proctoscope to evaluate the therapeutic effect of sclerotherapy with aluminum potassium sulfate and tannic acid (ALTA) for internal hemorrhoids: a prospective cohort study

BACKGROUND: 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. METHODS: 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. RESULTS: 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]. CONCLUSIONS: 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.