Cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a multi-center randomized controlled trial.
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 com...
| Publicado en: | Therapeutic Advances in Gastrointestinal Endoscopy pp. 1 - 12 |
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| Autores principales: | , , , , , , , , , , , , , , , , , , , |
| Formato: | pictorial protocol tables/charts Journal Article |
| Publicado: |
Sage Publications Inc.
6/5/2020
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=143652117&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 143652117 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 26317745 M8AA jtl: Therapeutic Advances in Gastrointestinal Endoscopy issn: 26317745 maglogo: Y pubinfo: dt: 6/5/2020 pid: 344 pub: Sage Publications Inc. place: Thousand Oaks, California artinfo: ui: 143652117 143652117 143652117 10.1177/2631774520925636 143652117 ppf: 1 ppct: 11 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a multi-center randomized controlled trial. aug: au: 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 affil: Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China sug: subj: Hemorrhoids Surgery Sclerotherapy Methods Endoscopy Sclerotherapy Equipment and Supplies Human Randomized Controlled Trials Random Assignment Multicenter Studies Prospective Studies Treatment Outcomes Data Analysis Software Chi Square Test Logistic Regression Wilcoxon Rank Sum Test ab: 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. pubtype: Academic Journal doctype: pictorial protocol tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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