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Tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial

BACKGROUND: Symptomatic hemorrhoids are one of the most common anorectal disorders. Many surgeons use tamponades after open hemorrhoidectomy to manage postoperative bleeding. The question of whether a tamponade is necessary and beneficial after hemorrhoidectomy has not yet been conclusively answered...

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Autores principales: Langenbach, Mike Ralf, Seidel, Dörthe
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6444871/
https://www.ncbi.nlm.nih.gov/pubmed/30940201
http://dx.doi.org/10.1186/s13063-019-3280-0
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author Langenbach, Mike Ralf
Seidel, Dörthe
author_facet Langenbach, Mike Ralf
Seidel, Dörthe
author_sort Langenbach, Mike Ralf
collection PubMed
description BACKGROUND: Symptomatic hemorrhoids are one of the most common anorectal disorders. Many surgeons use tamponades after open hemorrhoidectomy to manage postoperative bleeding. The question of whether a tamponade is necessary and beneficial after hemorrhoidectomy has not yet been conclusively answered. A previously conducted single-center pilot trial included 100 patients after Milligan–Morgan hemorrhoidectomy. The data indicated that insertion of an anal tamponade after hemorrhoidectomy does not reduce postoperative bleeding but causes significantly more pain. The findings of this pilot trial are now to be verified by means of a multicenter randomized clinical study called NoTamp. METHODS: We plan to include 953 patients after Milligan-Morgan or Parks hemorrhoidectomy in the NoTamp study. The aim is to demonstrate that using no tamponade dressing after open hemorrhoidectomy is not inferior to using tamponades with respect to postoperative bleeding, and that the patients report less pain. Primary endpoints of the trial are the maximum postoperative pain within 48 h and the incidence of severe postoperative bleeding that requires surgical revision within 7 days after the surgical procedure. Secondary endpoints of the study are the use of analgesics in the postoperative course, the lowest hemoglobin documented within 7 days, quality of life and patient satisfaction. Safety analysis includes all adverse and serious adverse events in relation to the study treatment. Further information can be found in the registration at the German Registry of Clinical Studies (DRKS00011590) and on the study webpage (https://notamp.de/en-GB/trial/main/setLocale/en_GB/). The study is financed by the HELIOS research funding. DISCUSSION: The study received full ethics committee approval. The first patient was enrolled on 3 May 2017. This trial will finally answer the question whether the insertion of a tamponade after open hemorrhoidectomy is necessary and beneficial. TRIAL REGISTRATION: German Clinical Trials Register (Deutsches Register Klinischer Studien (DRKS), DRKS00011590. Registered on 12 April 2017.
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spelling pubmed-64448712019-04-12 Tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial Langenbach, Mike Ralf Seidel, Dörthe Trials Study Protocol BACKGROUND: Symptomatic hemorrhoids are one of the most common anorectal disorders. Many surgeons use tamponades after open hemorrhoidectomy to manage postoperative bleeding. The question of whether a tamponade is necessary and beneficial after hemorrhoidectomy has not yet been conclusively answered. A previously conducted single-center pilot trial included 100 patients after Milligan–Morgan hemorrhoidectomy. The data indicated that insertion of an anal tamponade after hemorrhoidectomy does not reduce postoperative bleeding but causes significantly more pain. The findings of this pilot trial are now to be verified by means of a multicenter randomized clinical study called NoTamp. METHODS: We plan to include 953 patients after Milligan-Morgan or Parks hemorrhoidectomy in the NoTamp study. The aim is to demonstrate that using no tamponade dressing after open hemorrhoidectomy is not inferior to using tamponades with respect to postoperative bleeding, and that the patients report less pain. Primary endpoints of the trial are the maximum postoperative pain within 48 h and the incidence of severe postoperative bleeding that requires surgical revision within 7 days after the surgical procedure. Secondary endpoints of the study are the use of analgesics in the postoperative course, the lowest hemoglobin documented within 7 days, quality of life and patient satisfaction. Safety analysis includes all adverse and serious adverse events in relation to the study treatment. Further information can be found in the registration at the German Registry of Clinical Studies (DRKS00011590) and on the study webpage (https://notamp.de/en-GB/trial/main/setLocale/en_GB/). The study is financed by the HELIOS research funding. DISCUSSION: The study received full ethics committee approval. The first patient was enrolled on 3 May 2017. This trial will finally answer the question whether the insertion of a tamponade after open hemorrhoidectomy is necessary and beneficial. TRIAL REGISTRATION: German Clinical Trials Register (Deutsches Register Klinischer Studien (DRKS), DRKS00011590. Registered on 12 April 2017. BioMed Central 2019-04-02 /pmc/articles/PMC6444871/ /pubmed/30940201 http://dx.doi.org/10.1186/s13063-019-3280-0 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Langenbach, Mike Ralf
Seidel, Dörthe
Tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial
title Tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial
title_full Tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial
title_fullStr Tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial
title_full_unstemmed Tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial
title_short Tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial
title_sort tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6444871/
https://www.ncbi.nlm.nih.gov/pubmed/30940201
http://dx.doi.org/10.1186/s13063-019-3280-0
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