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©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
Endoscopic polidocanol foam sclerobanding for the treatment of grade II-III internal hemorrhoids: A prospective, multi-center, randomized study
Chun-Ying Qu, Fei-Yu Zhang, Wen Wang, Feng-Yu Gao, Wu-Lian Lin, Hao Zhang, Guang-Yu Chen, Yi Zhang, Ming-Ming Li, Zheng-Hong Li, Mei-Hong Cai, Lei-Ming Xu, Feng Shen
Chun-Ying Qu, Fei-Yu Zhang, Yi Zhang, Ming-Ming Li, Zheng-Hong Li, Mei-Hong Cai, Lei-Ming Xu, Feng Shen, Department of Gastroenterology & Endoscopy, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200092, China
Wen Wang, Wu-Lian Lin, Department of Gastroenterology, The 900th Hospital of the People’s Liberation Army Joint Service Support Force, Fuzhou 350025, Fujian Province, China
Feng-Yu Gao, Department of Endoscopy, Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Jinan 250014, Shandong Province, China
Hao Zhang, Department of Endoscopy, Baoshan People’s Hospital of Yunnan Province, Baoshan 678000, Yunnan Province, China
Guang-Yu Chen, Department of Gastroenterology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200092, China
Co-first authors: Chun-Ying Qu and Fei-Yu Zhang.
Co-corresponding authors: Lei-Ming Xu and Feng Shen.
Author contributions: Qu CY and Zhang FY contributed equally to this work as co-first authors; Xu LM and Shen F contributed equally to this work as co-corresponding authors; Qu CY and Zhang FY drafted the manuscript; Xu LM and Shen F designed the study and supervised its implementation; Chen GY analyzed the data; Qu CY, Wang W, Gao FY, Lin WL, Zhang H, Zhang Y, Li MM, Xu LM, and Shen F completed the endoscopic manipulations; Zhang FY, Li ZH and Cai MH participated in the experiments; and all authors made critical revisions and approved the final version to be published. The reasons for designating Xu LM and Shen F as co-corresponding authors are that Xu LM is responsible for multicenter coordination and quality control; Shen F is responsible for multi-center coordination and design of the project.
Supported by the Hospital Funded Clinical Research of Xinhua Hospital, No. 19XHCR16D.
Institutional review board statement: The study was reviewed and approved by the Institutional Review Boards of Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine and Ethics Committees of the Xinhua Hospital (Approval No. XHEC-C-2020-003-1).
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Data sharing statement: Consent was not obtained but the presented data are anonymized and risk of identification is low.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
https://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Feng Shen, MD, PhD, Chief Doctor, Department of Gastroenterology & Endoscopy, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, No. 1665 Kongjiang Road, Shanghai 200092, China. shenfeng01@xinhuamed.com.cn
Received: March 11, 2024
Revised: May 28, 2024
Accepted: June 14, 2024
Published online: July 21, 2024
Processing time: 122 Days and 5.8 Hours
BACKGROUND
Endoscopic rubber band ligation (ERBL) is a nonsurgical technique for the treatment of symptomatic internal hemorrhoids but is limited by recurrence and post-procedural pain.
AIM
To evaluate satisfaction, long-term recurrence, and post-procedural pain in managing internal hemorrhoids using a combination of polidocanol foam sclerotherapy and ERBL.
METHODS
This was a prospective, multicenter, randomized study. A total of 195 consecutive patients diagnosed with grade II-III internal hemorrhoids were enrolled from four tertiary hospitals and randomly divided into a cap-assisted endoscopic polidocanol foam sclerobanding (EFSB) or an ERBL group. All patients were followed-up for 12 months. Symptom-based severity and post-procedural pain were assessed using a hemorrhoid severity score (HSS) and a visual analog scale (VAS). Continuous variables were reported as medians and interquartile range.
RESULTS
One hundred and ninety-five patients were enrolled, with 98 in the EFSB group. HSS was lower in the EFSB group than in the ERBL group at 8 weeks [4.0 (3.0-5.0) vs 5.0 (4.0-6.0), P = 0.003] and 12-month [2.0 (1.0-3.0) vs 3.0 (2.0-3.0), P < 0.001] of follow-up. The prolapse recurrence rate was lower in the EFSB group at 12 months (11.2% vs 21.6%, P = 0.038). Multiple linear regression analysis demonstrated that EFSB treatment [B = -0.915, 95% confidence interval (CI): −1.301 to −0.530, P = 0.001] and rubber band number (B = 0.843, 95%CI: 0.595-1.092, P < 0.001) were negatively and independently associated with the VAS score 24 hours post-procedure. The median VAS was lower in the EFSB group than in the ERBL [2.0 (1.0-3.0) vs 3.0 (2.0-4.0), P < 0.001].
CONCLUSION
Cap-assisted EFSB provided long-term satisfaction and effective relief from the recurrence of prolapse and pain 24 hours post-procedure.
Core Tip: Endoscopic rubber band ligation (RBL) is a nonsurgical technique for the management of symptomatic internal hemorrhoids. However, it is constrained by recurrence and post-procedural pain. Endoscopic polidocanol foam sclerobanding (EFSB) is a novel approach known that has been proposed to address these challenges. In this study, we integrated endoscopic polidocanol foam sclerotherapy with RBL in patients presenting with grade II-III internal hemorrhoids and conducted a prospective, multicenter, randomized study to assess the long-term symptomatic and endoscopic efficacy of EFSB. Our findings demonstrated that EFSB offered long-term satisfaction and effective relief from prolapse recurrence and post-procedural pain.
