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

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机构： [1]Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China. [2]Department of Gastroenterology, First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, China. [3]Department of Holistic Integrative Medicine, Third People's Hospital of Shenzhen, Shenzhen, China. [4]Department of Gastroenterology, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China. [5]Department of Gastroenterology, Affiliated Hospital of Southwest Medical University, Luzhou, China. [6]Department of Gastroenterology, Hangzhou Xixi Hospital, Hangzhou, China. [7]Fourth Department of the Digestive Disease Center, Suining Central Hospital, Suining, China. [8]Department of Gastroenterology, Affiliated Hospital of Wuxi No. 2 People's Hospital of Nanjing Medical University, Wuxi, China. [9]Department of Gastroenterology, First Affiliated Hospital of Shihezi University Medical College, Shihezi, China. [10]Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. [11]Department of Gastroenterology, Tangdu Hospital, Fourth Military Medical University, Xi'an, China. [12]Department of Gastroenterology and Hepatology, Shenzhen University General Hospital, Shenzhen, China. [13]Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, China. [14]Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China. [15]Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan, Nanjing 210011, China. [16]Key Lab of Holistic Integrative Enterology, Nanjing Medical University, Nanjing, China

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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. 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. 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. ClinicalTrials.gov, NCT03917056. Registered on 12 April 2019. © The Author(s), 2020.

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最新[2025]版：

大类 | 3 区医学

小类 | 4 区胃肠肝病学

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无

最新[2023]版：

Q2 GASTROENTEROLOGY & HEPATOLOGY

影响因子： 3 最新[2023版] 2.4 最新五年平均 0 出版当年[2018版] 0 出版当年五年平均 0 出版前一年[2017版]

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第一作者机构： [1]Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.

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通讯作者：

通讯机构： [15]Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan, Nanjing 210011, China. [16]Key Lab of Holistic Integrative Enterology, Nanjing Medical University, Nanjing, China

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