1.A double-center randomized controlled study on endoscopic treatment for grade Ⅰ to Ⅲ internal hemorrhoids
Anling HE ; Chao MA ; Yong XIAO ; Ke ZHU ; Shuzhong LIU ; Mingkai CHEN
Chinese Journal of Digestive Endoscopy 2025;42(2):131-136
Objective:To evaluate the efficacy and safety of endoscopic injection sclerotherapy (EIS) and endoscopic rubber band ligation (ERBL) for the treatment of grade Ⅰ-Ⅲ internal hemorrhoids.Methods:A prospective study was conducted on patients with grade Ⅰ-Ⅲ internal hemorrhoids who sought treatment at Renmin Hospital of Wuhan University or the NO.2 People's Hospital of Fuyang City from November 2021 to November 2022. Eligible patients were continuously enrolled based on inclusion and exclusion criteria and randomized into 2 groups using a central randomization system: the EIS group and the ERBL group. The primary outcomes included symptom improvement rate, recurrence rate, incidence of adverse events (bleeding, anal distension, pain, urinary retention, etc.), surgical costs, patient satisfaction, hemorrhoidal disease symptom score (HDSS), European quality of life 5-dimensions (EQ-5D) score, and self-rated health status score.Results:A total of 203 patients were enrolled (86 from Renmin Hospital of Wuhan University and 117 from the NO.2 People's Hospital of Fuyang City), with 103 in the EIS group and 100 in the ERBL group. Both groups successfully completed endoscopic treatment for internal hemorrhoids. The surgical cost in the EIS group was significantly lower than that in the ERBL group (1 044.77±522.77 yuan VS 2 538.44±465.63 yuan, t=-21.660, P<0.001). The incidence of perioperative pain and moderate-to-severe pain in the EIS group was significantly lower than that in the ERBL group [2.91% (3/103) VS 25.00% (25/100), χ2=20.817, P<0.001; 0.97% (1/103) VS 18.00% (18/100), χ2=17.344, P<0.001]. There were no significant differences in the incidence of perioperative bleeding, anal distension, or urinary retention between the two groups [0.97% (1/103) VS 1.00% (1/100), 11.65% (12/103) VS 19.00% (19/100), 0.00% (0/103) VS 2.00% (2/100), P>0.05]. During the 12-week follow-up, 4 patients were lost to follow-up (all from the EIS group). There were no significant differences in symptom improvement rate, recurrence rate, or patient satisfaction rate between the two groups [96.97% (96/99) VS 96.00% (96/100), 3.03% (3/99) VS 5.00% (5/100), 97.98% (97/99) VS 95.00% (95/100), P>0.05]. At 12 weeks postoperatively, the HDSS in the EIS group significantly decreased compared to preoperative levels [0.0 (0.0, 1.0) VS 5.0 (3.0, 7.0), Z=-18.270, P<0.010], the EQ-5D score in the ERBL group significantly increased compared to preoperative levels (1.00±0.01 VS 0.98±0.03, F=27.527, P<0.010), and self-rated health status score in the ERBL group significantly increased compared to preoperative levels (92.31±6.89 VS 82.62±10.98, F=115.025, P<0.010). At 12 weeks postoperatively, the HDSS in the ERBL group significantly decreased compared to preoperative levels [0.0 (0.0, 1.0) VS 5.0 (4.0, 8.0), Z=-16.110, P<0.010], the EQ-5D score in the ERBL group significantly increased compared to preoperative levels (1.00±0.00 VS 0.98±0.05, F=13.718, P<0.010), and self-rated health status score in the ERBL group significantly increased compared to preoperative levels (93.46±6.35 VS 84.15±10.71, F=123.695, P<0.010). Conclusion:Both EIS and ERBL are safe and effective treatments for grade Ⅰ-Ⅲ internal hemorrhoids, with high patient satisfaction. Comparatively, EIS demonstrates lower surgical costs and a reduced incidence and severity of perioperative pain.
2.A double-center randomized controlled study on endoscopic treatment for grade Ⅰ to Ⅲ internal hemorrhoids
Anling HE ; Chao MA ; Yong XIAO ; Ke ZHU ; Shuzhong LIU ; Mingkai CHEN
Chinese Journal of Digestive Endoscopy 2025;42(2):131-136
Objective:To evaluate the efficacy and safety of endoscopic injection sclerotherapy (EIS) and endoscopic rubber band ligation (ERBL) for the treatment of grade Ⅰ-Ⅲ internal hemorrhoids.Methods:A prospective study was conducted on patients with grade Ⅰ-Ⅲ internal hemorrhoids who sought treatment at Renmin Hospital of Wuhan University or the NO.2 People's Hospital of Fuyang City from November 2021 to November 2022. Eligible patients were continuously enrolled based on inclusion and exclusion criteria and randomized into 2 groups using a central randomization system: the EIS group and the ERBL group. The primary outcomes included symptom improvement rate, recurrence rate, incidence of adverse events (bleeding, anal distension, pain, urinary retention, etc.), surgical costs, patient satisfaction, hemorrhoidal disease symptom score (HDSS), European quality of life 5-dimensions (EQ-5D) score, and self-rated health status score.Results:A total of 203 patients were enrolled (86 from Renmin Hospital of Wuhan University and 117 from the NO.2 People's Hospital of Fuyang City), with 103 in the EIS group and 100 in the ERBL group. Both groups successfully completed endoscopic treatment for internal hemorrhoids. The surgical cost in the EIS group was significantly lower than that in the ERBL group (1 044.77±522.77 yuan VS 2 538.44±465.63 yuan, t=-21.660, P<0.001). The incidence of perioperative pain and moderate-to-severe pain in the EIS group was significantly lower than that in the ERBL group [2.91% (3/103) VS 25.00% (25/100), χ2=20.817, P<0.001; 0.97% (1/103) VS 18.00% (18/100), χ2=17.344, P<0.001]. There were no significant differences in the incidence of perioperative bleeding, anal distension, or urinary retention between the two groups [0.97% (1/103) VS 1.00% (1/100), 11.65% (12/103) VS 19.00% (19/100), 0.00% (0/103) VS 2.00% (2/100), P>0.05]. During the 12-week follow-up, 4 patients were lost to follow-up (all from the EIS group). There were no significant differences in symptom improvement rate, recurrence rate, or patient satisfaction rate between the two groups [96.97% (96/99) VS 96.00% (96/100), 3.03% (3/99) VS 5.00% (5/100), 97.98% (97/99) VS 95.00% (95/100), P>0.05]. At 12 weeks postoperatively, the HDSS in the EIS group significantly decreased compared to preoperative levels [0.0 (0.0, 1.0) VS 5.0 (3.0, 7.0), Z=-18.270, P<0.010], the EQ-5D score in the ERBL group significantly increased compared to preoperative levels (1.00±0.01 VS 0.98±0.03, F=27.527, P<0.010), and self-rated health status score in the ERBL group significantly increased compared to preoperative levels (92.31±6.89 VS 82.62±10.98, F=115.025, P<0.010). At 12 weeks postoperatively, the HDSS in the ERBL group significantly decreased compared to preoperative levels [0.0 (0.0, 1.0) VS 5.0 (4.0, 8.0), Z=-16.110, P<0.010], the EQ-5D score in the ERBL group significantly increased compared to preoperative levels (1.00±0.00 VS 0.98±0.05, F=13.718, P<0.010), and self-rated health status score in the ERBL group significantly increased compared to preoperative levels (93.46±6.35 VS 84.15±10.71, F=123.695, P<0.010). Conclusion:Both EIS and ERBL are safe and effective treatments for grade Ⅰ-Ⅲ internal hemorrhoids, with high patient satisfaction. Comparatively, EIS demonstrates lower surgical costs and a reduced incidence and severity of perioperative pain.
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