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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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7278306/
https://www.ncbi.nlm.nih.gov/pubmed/32551439
http://dx.doi.org/10.1177/2631774520925636
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author 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
author_facet 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
author_sort Wu, Xia
collection PubMed
description 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.
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spelling pubmed-72783062020-06-17 Cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a multi-center randomized controlled trial 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 Ther Adv Gastrointest Endosc Study Protocol 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. SAGE Publications 2020-06-05 /pmc/articles/PMC7278306/ /pubmed/32551439 http://dx.doi.org/10.1177/2631774520925636 Text en © The Author(s), 2020 https://creativecommons.org/licenses/by/4.0/ This article is distributed under the terms of the Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Study Protocol
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
Cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a multi-center randomized controlled trial
title Cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a multi-center randomized controlled trial
title_full Cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a multi-center randomized controlled trial
title_fullStr Cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a multi-center randomized controlled trial
title_full_unstemmed Cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a multi-center randomized controlled trial
title_short Cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a multi-center randomized controlled trial
title_sort cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a multi-center randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7278306/
https://www.ncbi.nlm.nih.gov/pubmed/32551439
http://dx.doi.org/10.1177/2631774520925636
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