The rationale, design, and methods of a randomized, controlled trial to evaluate the efficacy of single-dose dexamethasone in reducing post-embolization syndrome in patients undergoing uterine artery embolization
BACKGROUND: Uterine artery embolization (UAE) is a minimally invasive technique well established for treating symptomatic uterine fibroids. However, the post-procedure recovery for UAE involves a notable inflammatory process in response to ischemia known as post-embolization syndrome (PES). PES enco...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Elsevier
2018
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6174256/ https://www.ncbi.nlm.nih.gov/pubmed/30302416 http://dx.doi.org/10.1016/j.conctc.2018.09.006 |
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author | Wang, Melinda Kohi, Maureen P. |
author_facet | Wang, Melinda Kohi, Maureen P. |
author_sort | Wang, Melinda |
collection | PubMed |
description | BACKGROUND: Uterine artery embolization (UAE) is a minimally invasive technique well established for treating symptomatic uterine fibroids. However, the post-procedure recovery for UAE involves a notable inflammatory process in response to ischemia known as post-embolization syndrome (PES). PES encompasses transient leukocytosis, low-grade fever, and can result in readmission of up to 10% of patients. In surgical settings, multiple studies have demonstrated the efficacy of glucocorticoids in reducing inflammation and associated pain. However, this approach has not yet been assessed in predominantly ischemia-driven PES. METHODS: This paper describes the protocol of a prospective randomized, double-blind, placebo-controlled, multi-center trial to test the efficacy and safety of single-dose dexamethasone on inflammatory responses, pain, nausea, and readmission rates after UAE. The study will enroll pre-menopausal patients between 25 and 55 years (planned enrollment, n = 60) with MRI confirmed symptomatic fibroids. Patients will be randomly allocated into two groups: single-dose intravenous dexamethasone plus standard of care or placebo (normal saline) plus standard of care. RESULTS: The primary endpoint is the patient pain score 4 h following the UAE procedure. Secondary endpoints include pain scores at 7 h and 24 h following UAE; narcotic usage in the first 24 h following UAE; and serum inflammatory markers (white blood cell count, C-reactive protein [CRP], interleukin-6 [IL-6], and cortisol) 24 h after UAE. CONCLUSION: Given the high incidence of post-procedure pain and difficulty with pain control after uterine artery embolization, results of this trial may directly influence the standard of care in perioperative management of patients undergoing UAE. |
format | Online Article Text |
id | pubmed-6174256 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-61742562018-10-09 The rationale, design, and methods of a randomized, controlled trial to evaluate the efficacy of single-dose dexamethasone in reducing post-embolization syndrome in patients undergoing uterine artery embolization Wang, Melinda Kohi, Maureen P. Contemp Clin Trials Commun Article BACKGROUND: Uterine artery embolization (UAE) is a minimally invasive technique well established for treating symptomatic uterine fibroids. However, the post-procedure recovery for UAE involves a notable inflammatory process in response to ischemia known as post-embolization syndrome (PES). PES encompasses transient leukocytosis, low-grade fever, and can result in readmission of up to 10% of patients. In surgical settings, multiple studies have demonstrated the efficacy of glucocorticoids in reducing inflammation and associated pain. However, this approach has not yet been assessed in predominantly ischemia-driven PES. METHODS: This paper describes the protocol of a prospective randomized, double-blind, placebo-controlled, multi-center trial to test the efficacy and safety of single-dose dexamethasone on inflammatory responses, pain, nausea, and readmission rates after UAE. The study will enroll pre-menopausal patients between 25 and 55 years (planned enrollment, n = 60) with MRI confirmed symptomatic fibroids. Patients will be randomly allocated into two groups: single-dose intravenous dexamethasone plus standard of care or placebo (normal saline) plus standard of care. RESULTS: The primary endpoint is the patient pain score 4 h following the UAE procedure. Secondary endpoints include pain scores at 7 h and 24 h following UAE; narcotic usage in the first 24 h following UAE; and serum inflammatory markers (white blood cell count, C-reactive protein [CRP], interleukin-6 [IL-6], and cortisol) 24 h after UAE. CONCLUSION: Given the high incidence of post-procedure pain and difficulty with pain control after uterine artery embolization, results of this trial may directly influence the standard of care in perioperative management of patients undergoing UAE. Elsevier 2018-09-29 /pmc/articles/PMC6174256/ /pubmed/30302416 http://dx.doi.org/10.1016/j.conctc.2018.09.006 Text en © 2018 Published by Elsevier Inc. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Article Wang, Melinda Kohi, Maureen P. The rationale, design, and methods of a randomized, controlled trial to evaluate the efficacy of single-dose dexamethasone in reducing post-embolization syndrome in patients undergoing uterine artery embolization |
title | The rationale, design, and methods of a randomized, controlled trial to evaluate the efficacy of single-dose dexamethasone in reducing post-embolization syndrome in patients undergoing uterine artery embolization |
title_full | The rationale, design, and methods of a randomized, controlled trial to evaluate the efficacy of single-dose dexamethasone in reducing post-embolization syndrome in patients undergoing uterine artery embolization |
title_fullStr | The rationale, design, and methods of a randomized, controlled trial to evaluate the efficacy of single-dose dexamethasone in reducing post-embolization syndrome in patients undergoing uterine artery embolization |
title_full_unstemmed | The rationale, design, and methods of a randomized, controlled trial to evaluate the efficacy of single-dose dexamethasone in reducing post-embolization syndrome in patients undergoing uterine artery embolization |
title_short | The rationale, design, and methods of a randomized, controlled trial to evaluate the efficacy of single-dose dexamethasone in reducing post-embolization syndrome in patients undergoing uterine artery embolization |
title_sort | rationale, design, and methods of a randomized, controlled trial to evaluate the efficacy of single-dose dexamethasone in reducing post-embolization syndrome in patients undergoing uterine artery embolization |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6174256/ https://www.ncbi.nlm.nih.gov/pubmed/30302416 http://dx.doi.org/10.1016/j.conctc.2018.09.006 |
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