Abstract
Background
Endoscopic rubber band ligation (ERBL) is considered an effective nonsurgical treatment for symptomatic grade I to III hemorrhoids; however, it is unclear whether ligation of hemorrhoids or simultaneous ligation of hemorrhoids and proximal normal mucosa (combined ligation) is safer and more effective. This controlled, open-label, and prospective study aimed to evaluate the efficacy and safety of both methods for symptomatic grade I to III hemorrhoids.
Methods
Seventy patients with symptomatic grade I to III hemorrhoids were randomly assigned to the hemorrhoid and combined ligation groups (35 in each group). Patients were followed up at 3, 6, and 12 months to assess symptom improvement, complications, and recurrence. The primary outcome was overall therapeutic success rate (complete resolution and partial resolution rates). The secondary outcomes included recurrence rate and efficacy for each symptom. Complications and patient satisfaction were also assessed.
Results
Sixty-two patients (31 in each group) completed the 12-month follow-up; 42 (67.8%) experienced complete resolution, 17 (27.4%) experienced partial resolution, and 3 (4.8%) experienced no change in overall efficacy. The rates of complete resolution, partial resolution, and no change in the hemorrhoid ligation and combined ligation groups were 71.0 and 64.5%, 22.6 and 32.3%, and 6.5 and 3.2%, respectively. No significant differences in overall efficacy, recurrence rate, or efficacy for each symptom (including bleeding, prolapse, pain, anal swelling, itching, soiling, and constipation) were observed between groups. No life-threatening events requiring surgical intervention occurred. The incidence of postoperative pain was higher in the combined ligation group (74.2% vs. 45.2%, P = 0.02). No significant differences between groups in terms of incidences of other complications or patient satisfaction were observed.
Conclusion
Both methods achieved satisfactory therapeutic effects. No significant differences in efficacy and safety of the two ligation methods were observed; however, combined ligation resulted in a higher incidence of postprocedural pain.
Graphical Abstract
Similar content being viewed by others
References
Wu X, Wen Q, Cui B, Liu Y, Zhong M, Yuan Y, Wu L, Zhang X, Hu Y, Lv M, Wu Q, He S, Jin Y, Tian S, Wan R, Wang X, Xu L, Bai J, Huang G, Ji G, Zhang F (2020) Cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a multi-center randomized controlled trial. Ther Adv Gastrointest Endosc 13:2631774520925636
Johannsson HO, Graf W, Pahlman L (2005) Bowel habits in hemorrhoid patients and normal subjects. Am J Gastroenterol 100:401–406
Lohsiriwat V (2015) Treatment of hemorrhoids: a coloproctologist’s view. World J Gastroenterol 21:9245–9252
Schleinstein HP, Averbach M, Averbach P, Correa P, Popoutchi P, Rossini LGB (2019) Endoscopic band ligation for the treatment of hemorrhoidal disease. Arq Gastroenterol 56:22–27
van Tol RR, Kleijnen J, Watson AJM, Jongen J, Altomare DF, Qvist N, Higuero T, Muris JWM, Breukink SO (2020) European society of coloproctology: guideline for haemorrhoidal disease. Colorectal Dis 22:650–662
Ma W, Guo J, Yang F, Dietrich CF, Sun S (2020) Progress in endoscopic treatment of hemorrhoids. J Transl Int Med 8:237–244
Fukuda A, Kajiyama T, Arakawa H, Kishimoto H, Someda H, Sakai M, Tsunekawa S, Chiba T (2004) Retroflexed endoscopic multiple band ligation of symptomatic internal hemorrhoids. Gastrointest Endosc 59:380–384
Nystrom PO, Qvist N, Raahave D, Lindsey I, Mortensen N, Stapled or Open Pile Procedure trial study g, (2010) Randomized clinical trial of symptom control after stapled anopexy or diathermy excision for haemorrhoid prolapse. Br J Surg 97:167–176
Jun L et al (2021) Chinese digestive endoscopic practice guidelines and operation consensus for internal hemorrhoids (2021). Chin J Dig Endosc 38:676–687
Chow SC, Shao J, Wang HS (2003) Sample size calculations in clinical research. Marcel Dekker Inc, New York
Abiodun AA, Alatise OI, Okereke CE, Adesunkanmi AK, Eletta EA, Gomna A (2020) Comparative study of endoscopic band ligation versus injection sclerotherapy with 50% dextrose in water, in symptomatic internal haemorrhoids. Niger Postgrad Med J 27:13–20
Salgueiro P, Rei A, Garrido M, Rosa B, Oliveira AM, Pereira-Guedes T, Morais S, Castro-Pocas F (2022) Polidocanol foam sclerotherapy in the treatment of hemorrhoidal disease in patients with bleeding disorders: a multicenter, prospective, cohort study. Tech Coloproctol 26:615–625
Agachan F, Chen T, Pfeifer J, Reissman P, Wexner SD (1996) A constipation scoring system to simplify evaluation and management of constipated patients. Dis Colon Rectum 39:681–685
Komporozos V, Ziozia V, Komporozou A, Stravodimos G, Kolinioti A, Papazoglou A (2021) Rubber band ligation of symptomatic hemorrhoids: an old solution to an everyday problem. Int J Colorectal Dis 36:1723–1729
Komborozos VA, Skrekas GJ, Pissiotis CA (2000) Rubber band ligation of symptomatic internal hemorrhoids: results of 500 cases. Dig Surg 17:71–76
Committee AT, Siddiqui UD, Barth BA, Banerjee S, Bhat YM, Chauhan SS, Gottlieb KT, Konda V, Maple JT, Murad FM, Pfau P, Pleskow D, Tokar JL, Wang A, Rodriguez SA (2014) Devices for the endoscopic treatment of hemorrhoids. Gastrointest Endosc 79:8–14
Wehrmann T, Riphaus A, Feinstein J, Stergiou N (2004) Hemorrhoidal elastic band ligation with flexible videoendoscopes: a prospective, randomized comparison with the conventional technique that uses rigid proctoscopes. Gastrointest Endosc 60:191–195
Zaher T, Ibrahim I, Ibrahim A (2011) Endoscopic band ligation of internal haemorrhoids versus stapled haemorrhoidopexy in patients with portal hypertension. Arab J Gastroenterol 12:11–14
Miyamoto H (2023) Minimally invasive treatment for advanced hemorrhoids. J Anus Rectum Colon 7:8–16
El Nakeeb AM, Fikry AA, Omar WH, Fouda EM, El Metwally TA, Ghazy HE, Badr SA, Abu Elkhar MY, Elawady SM, Abd Elmoniam HH, Khafagy WW, Morshed MM, El Lithy RE, Farid ME (2008) Rubber band ligation for 750 cases of symptomatic hemorrhoids out of 2200 cases. World J Gastroenterol 14:6525–6530
Sajid MS, Bhatti MI, Caswell J, Sains P, Baig MK (2015) Local anaesthetic infiltration for the rubber band ligation of early symptomatic haemorrhoids: a systematic review and meta-analysis. Updates Surg 67:3–9
Acknowledgements
The authors thank all study participants who participated in the present study.
Funding
The present study was funded by the Clinical Capacity Enhancement Project of the First Affiliated Hospital of Nanjing Medical University (JSPH-MC-2022–5). The funder had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Author information
Authors and Affiliations
Contributions
WC, YG, and LT were involved in the study conception and study design. WC and YG obtained the funding. All authors were involved in the implementation of the study and interpreting the data. LT, CY, YQ, and YG participated in the statistics of the study. LT and YG, with the help of WC, wrote the manuscript. All authors have read and approved the final manuscript.
Corresponding authors
Ethics declarations
Disclosures
Drs. Li Tian, Chun Yu, Yue Qin, Yaoyao Gong, and Wenfang Cheng have no conflicts of interests or financial ties to disclose.
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Supplementary Information
Below is the link to the electronic supplementary material.
Rights and permissions
Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.
About this article
Cite this article
Tian, L., Yu, C., Qin, Y. et al. Efficacy of two endoscopic rubber band ligation methods for symptomatic hemorrhoids: a randomized controlled trial. Surg Endosc 37, 6235–6245 (2023). https://doi.org/10.1007/s00464-023-10108-8
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00464-023-10108-8