Cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a multi-center randomized controlled trial. (June 2020)

• Record Type: Journal Article
• Authors: Wu, Xia; Wen, Quan; Cui, Bota; Liu, Yafei; Zhong, Min; Yuan, Yu; Wu, Lihao; Zhang, Xiaoyin; Hu, Yunlian; Lv, Muhan; Wu, Qianneng; He, Suyu; Jin, Yan; Tian, Shuxin; Wan, Rong; Wang, Xin; Xu, Long; Bai, Jianling; Huang, Guangming; Ji, Guozhong; Zhang, Faming
• Is Part Of: Clinical medicine insights. Volume 13(2020)
• Publication Date: 2020-06
• Subjects: cap-assisted endoscopic sclerotherapy -- endoscopy -- hemorrhoids -- prolapse -- randomized controlled trial -- sclerotherapy; Gastrointestinal system -- Diseases -- Periodicals; Gastroenterology -- Periodicals; Gastroenterology; Gastrointestinal Diseases; Gastroenterology; Gastrointestinal system -- Diseases; Electronic journals; Periodicals; Periodicals; 616.33005
• DOI: 10.1177/2631774520925636
• Languages: English
• ISSNs: 1179-5522

Abstract

Background: Cap-assisted endoscopic sclerotherapy is a new interventional therapy for internal hemorrhoids and rectal prolapse under colonoscopy. The proper length of the endoscopic injection needle is the core for performing cap-assisted endoscopic sclerotherapy well with more benefits and less complications. However, no data are currently available to guide endoscopists to consider the length of injection needle before cap-assisted endoscopic sclerotherapy. This study is designed to evaluate the efficacy and safety of cap-assisted endoscopic sclerotherapy with long or short injection needle in the treatment of internal hemorrhoids. Methods: This is a nationwide multi-center, prospective, single-blind and randomized controlled trial. Patients with grade I-II internal hemorrhoids who have failed to conservative treatments and grade III internal hemorrhoids who are not suitable for surgery or refuse surgery will be included. Participants will be randomized 1:1 into either long or short injection needle group. The primary outcome is the recurrence rate of internal hemorrhoids 24 weeks after cap-assisted endoscopic sclerotherapy. The secondary outcomes are as follows: (1) symptom severity score, (2) three-level EuroQoL five dimensions health scale scores, (3) occurrence of adverse events and severe adverse events, and (4) patients' attitudes toward cap-assisted endoscopic sclerotherapy. Data collection will be conducted before and during operation, the 1st day, 1st week, 2nd week, and 24th week after cap-assisted endoscopic sclerotherapy. Discussion: The outcome of this study is expected to provide a practical clinical protocol of cap-assisted endoscopic sclerotherapy for patients with internal hemorrhoids and promote the use of this new endoscopic technique. Trial registration: ClinicalTrials.gov, NCT03917056. Registered on 12 April 2019.