Pressure dressings versus nonpressure dressings after hemorrhoidectomy: study protocol for a randomized controlled trial

Abstract Background Pressure dressings have been used after open hemorrhoidectomy to protect surgical wounds and manage postoperative bleeding for many years. However, pressure dressings may increase the incidence of postoperative complications, such as urinary retention, medical adhesive-related sk...

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Autores principales:	Ping Xue, Jing Wu, Ping Zhu, Dan Wang, Mei Xu, Yi Zhang, Guanmao Lu, Quanyi Chen, Qin Zhang, Renjin Tang, Jinbo Fang
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Hemorrhoids Hemorrhoidectomy Urinary retention Postoperative pain Postoperative bleeding Pressure dressing Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/3158ad3f53e6431ea95ff2ab37046e8a
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spelling	oai:doaj.org-article:3158ad3f53e6431ea95ff2ab37046e8a2021-11-14T12:31:05ZPressure dressings versus nonpressure dressings after hemorrhoidectomy: study protocol for a randomized controlled trial10.1186/s13063-021-05750-31745-6215https://doaj.org/article/3158ad3f53e6431ea95ff2ab37046e8a2021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05750-3https://doaj.org/toc/1745-6215Abstract Background Pressure dressings have been used after open hemorrhoidectomy to protect surgical wounds and manage postoperative bleeding for many years. However, pressure dressings may increase the incidence of postoperative complications, such as urinary retention, medical adhesive-related skin injury, and pain. A previous controlled trial included 67 patients who underwent Milligan-Morgan hemorrhoidectomy. The data indicated that the use of a nonpressure dressing after hemorrhoidectomy reduces the incidence of urinary retention and catheterization. However, the incidence of severe postoperative bleeding and other postoperative complications was not assessed. There is no consensus on whether it is necessary and beneficial to use a nonpressure dressing after hemorrhoidectomy. The results of this randomized clinical study will help answer this question. Methods In this study, we plan to include 186 patients who have undergone modified Milligan-Morgan hemorrhoidectomy, which only sutured external hemorrhoids to reduce the risk of bleeding. The purpose is to determine whether the use of nonpressure dressings after open hemorrhoidectomy is inferior to the use of pressure dressings in terms of severe postoperative bleeding and postoperative complications. The primary endpoints of the trial are the incidence of urinary retention within 24 h after surgery and the incidence of severe postoperative bleeding 1 h after dressing removal, which requires revision surgery within 24 h after the surgery. The secondary endpoints of the study are the pain score, anal distension score, postoperative use of analgesics, and incidence of medical adhesive-related skin injury, all of which will be assessed before removing the dressings. The length of hospitalization in days and hospitalization expenses will be recorded. Safety will be assessed with consideration of all adverse and severe adverse events related to the study treatment. Discussion The study received full ethics committee approval. The first patient was enrolled on 27 November 2020. The results of this trial will finally answer the question of whether a nonpressure dressing after open hemorrhoidectomy is necessary and beneficial. Trial registration Chinese Clinical Trial Registry ChiCTR2000040283 . Registered on 28 November 2020.Ping XueJing WuPing ZhuDan WangMei XuYi ZhangGuanmao LuQuanyi ChenQin ZhangRenjin TangJinbo FangBMCarticleHemorrhoidsHemorrhoidectomyUrinary retentionPostoperative painPostoperative bleedingPressure dressingMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-8 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Hemorrhoids Hemorrhoidectomy Urinary retention Postoperative pain Postoperative bleeding Pressure dressing Medicine (General) R5-920
spellingShingle	Hemorrhoids Hemorrhoidectomy Urinary retention Postoperative pain Postoperative bleeding Pressure dressing Medicine (General) R5-920 Ping Xue Jing Wu Ping Zhu Dan Wang Mei Xu Yi Zhang Guanmao Lu Quanyi Chen Qin Zhang Renjin Tang Jinbo Fang Pressure dressings versus nonpressure dressings after hemorrhoidectomy: study protocol for a randomized controlled trial
description	Abstract Background Pressure dressings have been used after open hemorrhoidectomy to protect surgical wounds and manage postoperative bleeding for many years. However, pressure dressings may increase the incidence of postoperative complications, such as urinary retention, medical adhesive-related skin injury, and pain. A previous controlled trial included 67 patients who underwent Milligan-Morgan hemorrhoidectomy. The data indicated that the use of a nonpressure dressing after hemorrhoidectomy reduces the incidence of urinary retention and catheterization. However, the incidence of severe postoperative bleeding and other postoperative complications was not assessed. There is no consensus on whether it is necessary and beneficial to use a nonpressure dressing after hemorrhoidectomy. The results of this randomized clinical study will help answer this question. Methods In this study, we plan to include 186 patients who have undergone modified Milligan-Morgan hemorrhoidectomy, which only sutured external hemorrhoids to reduce the risk of bleeding. The purpose is to determine whether the use of nonpressure dressings after open hemorrhoidectomy is inferior to the use of pressure dressings in terms of severe postoperative bleeding and postoperative complications. The primary endpoints of the trial are the incidence of urinary retention within 24 h after surgery and the incidence of severe postoperative bleeding 1 h after dressing removal, which requires revision surgery within 24 h after the surgery. The secondary endpoints of the study are the pain score, anal distension score, postoperative use of analgesics, and incidence of medical adhesive-related skin injury, all of which will be assessed before removing the dressings. The length of hospitalization in days and hospitalization expenses will be recorded. Safety will be assessed with consideration of all adverse and severe adverse events related to the study treatment. Discussion The study received full ethics committee approval. The first patient was enrolled on 27 November 2020. The results of this trial will finally answer the question of whether a nonpressure dressing after open hemorrhoidectomy is necessary and beneficial. Trial registration Chinese Clinical Trial Registry ChiCTR2000040283 . Registered on 28 November 2020.
format	article
author	Ping Xue Jing Wu Ping Zhu Dan Wang Mei Xu Yi Zhang Guanmao Lu Quanyi Chen Qin Zhang Renjin Tang Jinbo Fang
author_facet	Ping Xue Jing Wu Ping Zhu Dan Wang Mei Xu Yi Zhang Guanmao Lu Quanyi Chen Qin Zhang Renjin Tang Jinbo Fang
author_sort	Ping Xue
title	Pressure dressings versus nonpressure dressings after hemorrhoidectomy: study protocol for a randomized controlled trial
title_short	Pressure dressings versus nonpressure dressings after hemorrhoidectomy: study protocol for a randomized controlled trial
title_full	Pressure dressings versus nonpressure dressings after hemorrhoidectomy: study protocol for a randomized controlled trial
title_fullStr	Pressure dressings versus nonpressure dressings after hemorrhoidectomy: study protocol for a randomized controlled trial
title_full_unstemmed	Pressure dressings versus nonpressure dressings after hemorrhoidectomy: study protocol for a randomized controlled trial
title_sort	pressure dressings versus nonpressure dressings after hemorrhoidectomy: study protocol for a randomized controlled trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/3158ad3f53e6431ea95ff2ab37046e8a
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Pressure dressings versus nonpressure dressings after hemorrhoidectomy: study protocol for a randomized controlled trial

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