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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Autores principales: Wang, Melinda, Kohi, Maureen P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2018
Materias:
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.
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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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