Objective To investigate the clinical effects of modified automatic hemorrhoidal ligation using elastic string (RPH‑4) combined with Xiaozhilling injection for grade Ⅲ hemorrhoids.

Methods The prospective randomized controlled study was conducted. The clinical data of patients with grade Ⅲ hemorrhoids who underwent modified RPH‑4 combined with Xiaozhiling injection in Traditional Chinese Medicine Hospital of Chongqing Shapingba District from July 2021 to December 2022 were selected. Patients with grade Ⅲ hemorrhoids who meeting the inclusion criteria were randomly divided into the experimental group and the control group using a random number table method. Patients in the experiment group underwent submucosal injection of the Xiaozhilling injec-tion followed by modified RPH‑4, and patients in the control group underwent submucosal injection of the 0.9% sodium chloride solution followed by modified RPH‑4. Observation indicators: (1) grouping of enrolled patients; (2) postoperative situations; (3) short‑term efficacy; (4) long‑term efficacy. Com-parison of measurement data with normal distribution between groups was conducted using the inde-pendent sample t test. Comparison of measurement data with skewed distribution between groups was conducted using the nonparameter test. Comparison of count data between groups was conducted using the chi‑square test or Fisher exact probability.

Results (1) Grouping of enrolled patients. A total of 120 patients were selected. There were 72 males and 48 females, aged 48(range, 18-69)years, including 60 cases in the experiment group and 60 cases in the control group, respectively. There was no significant difference in gender, age, type of hemorrhoids, time to hemorrhoid prolapsis, stool blood, symptom score and Wexner score between the two groups (P>0.05), confounding bias ensured comparability. At the end of the study, there were 59 cases in the experimental group and 58 cases in the control group. (2) Postoperative situations. There were 5 cases of secondary bleeding after modified RPH‑4 in the experiment group and 15 cases of secondary bleeding after modified RPH‑4 in the control group, showing a significant difference between the two groups (χ²=6.239, P<0.05). The post-operative hemorrhoidal shedding time was (6.9±1.4)days in the experiment group, versus (8.1±2.2)days in the control group, showing a significant difference between the two groups (t=-3.566, P<0.05). (3) Short-term efficacy. There were 59 cases in the experiment group and 58 cases in the control group completing short‑term follow‑up. The cure rate was 88.14%(52/59) in the experiment group, versus 84.48%(49/58) in the control group, showing no significant difference in short‑term efficacy between the two groups (χ²=0.331, P>0.05). The wound healing time was (24±5)days in the experi-ment group, versus (25±5)days in the control group, showing no significant difference between the two groups (t=-1.082, P>0.05). (4) Long‑term efficacy. There were 59 cases in the experiment group and 58 cases in the control group completing long‑term follow‑up. None of patient in the two groups had anal incontinence. Cases of hemorrhoid recurrence (blood stool or prolapse) and cases of rectal hard segment in the experiment group were 2 and 1, respectively, and there was no anorectal stenosis. Cases of hemorrhoid recurrence (blood stool or prolapse) and cases of anorectal stenosis were 8 and 1, respectively, and there was no rectal hard segment. There was no significant difference of above situations between the two groups (P>0.05).

Conclusion The modified RPH‑4 combined with Xiaozhiling injection for grade Ⅲ hemorrhoids can achieve double solid and hemorrhoidal removal efficacy, which can further reduce the risk of complications after severe hemorrhoids modified RPH‑4 alone treatment.