Postoperative intravenously administered iron sucrose versus postoperative orally administered iron to treat post-bariatric abdominoplasty anaemia (ISAPA): the study protocol for a randomised controlled trial

Background: Anaemia and iron deficiency are common complications following post-bariatric abdominoplasty. Given the low oral absorbability of iron resulting from bariatric surgery, it has been hypothesised that postoperative intravenously administered iron supplementation could be used to treat anae...

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Autores: Montano-Pedroso, Juan Carlos [UNIFESP], Garcia, Elvio Bueno [UNIFESP], Novo, Neil Ferreira [UNIFESP], Veiga, Daniela Francescato [UNIFESP], Ferreira, Lydia Masako [UNIFESP]
Tipo de documento: artigo
Estado:Versão publicada
Data de publicação:2016
País:Brasil
Recursos:Universidade Federal de São Paulo (UNIFESP)
Repositório:Repositório Institucional da UNIFESP
Idioma:inglês
OAI Identifier:oai:repositorio.unifesp.br:11600/56053
Acesso em linha:http://dx.doi.org/10.1186/s13063-016-1300-x
https://repositorio.unifesp.br/handle/11600/56053
Access Level:Acceso aberto
Palavra-chave:Anaemia
Iron
Abdominal wall
Plastic surgery
Bariatric surgery
Haemoglobin
Adult
Female
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spelling Postoperative intravenously administered iron sucrose versus postoperative orally administered iron to treat post-bariatric abdominoplasty anaemia (ISAPA): the study protocol for a randomised controlled trialAnaemiaIronAbdominal wallPlastic surgeryBariatric surgeryHaemoglobinAdultFemaleBackground: Anaemia and iron deficiency are common complications following post-bariatric abdominoplasty. Given the low oral absorbability of iron resulting from bariatric surgery, it has been hypothesised that postoperative intravenously administered iron supplementation could be used to treat anaemia and to prevent the development of iron deficiency in these patients. Methods/Design: In this multicentre open-label randomised clinical trial, 56 adult women undergoing post-bariatric anchor-line abdominoplasty will be allocated at a ratio of 1: 1 for postoperative supplementation with two intravenously administered applications of 200 mg of iron saccharate or postoperative supplementation with 100 mg of iron polymaltose complex administered orally, twice a day for 8 weeks. The primary outcome is the difference in mean haemoglobin levels between the two groups at eight postoperative weeks. Secondary outcomes evaluated at one, four and eight postoperative weeks include iron profile, reticulocyte count, overall quality of life measured using the Short-Form 36 Health Survey (SF-36) questionnaire, fatigue measured using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F), adverse effects and postoperative complications. Discussion: This randomised clinical trial aims to evaluate the haematopoietic effectiveness of intravenously administered iron supplementation in patients undergoing post- bariatric abdominoplasty. A more effective recovery of haemoglobin levels could help improve the patients' quality of life and could provide an improved haematological status in preparation for the subsequent and frequent plastic surgeries these patients undergo.Univ Fed Sao Paulo, Div Plast Surg, Grad Program Translat Surg, Rua Napoleao Barros 725,4th Floor,Vila Clementino, BR-04024002 Sao Paulo, SP, BrazilUniv Fed Sao Paulo, Div Plast Surg, Grad Program Translat Surg, Rua Napoleao Barros 725,4th Floor,Vila Clementino, BR-04024002 Sao Paulo, SP, BrazilWeb of ScienceSao Paulo Research Foundation (Fundacao de Amparo a Pesquisa do Estado de Sao Paulo - FAPESP) [2014/07710-6]FAPESP: 2014/07710-6Biomed Central Ltd2020-07-22T13:23:08Z2020-07-22T13:23:08Z2016info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion-application/pdfhttp://dx.doi.org/10.1186/s13063-016-1300-xTrials. London, v. 17, p. -, 2016.10.1186/s13063-016-1300-xWOS000373776600001.pdf1745-6215https://repositorio.unifesp.br/handle/11600/56053WOS:000373776600001ark:/48912/001300001rzfkengTrialsLondoninfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UNIFESPinstname:Universidade Federal de São Paulo (UNIFESP)instacron:UNIFESPMontano-Pedroso, Juan Carlos [UNIFESP]Garcia, Elvio Bueno [UNIFESP]Novo, Neil Ferreira [UNIFESP]Veiga, Daniela Francescato [UNIFESP]Ferreira, Lydia Masako [UNIFESP]2024-08-11T09:50:46Zoai:repositorio.unifesp.br:11600/56053Repositório InstitucionalPUBhttp://www.repositorio.unifesp.br/oai/requestbiblioteca.csp@unifesp.bropendoar:34652024-08-11T09:50:46Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP)false
dc.title.none.fl_str_mv Postoperative intravenously administered iron sucrose versus postoperative orally administered iron to treat post-bariatric abdominoplasty anaemia (ISAPA): the study protocol for a randomised controlled trial
title Postoperative intravenously administered iron sucrose versus postoperative orally administered iron to treat post-bariatric abdominoplasty anaemia (ISAPA): the study protocol for a randomised controlled trial
spellingShingle Postoperative intravenously administered iron sucrose versus postoperative orally administered iron to treat post-bariatric abdominoplasty anaemia (ISAPA): the study protocol for a randomised controlled trial
Montano-Pedroso, Juan Carlos [UNIFESP]
Anaemia
Iron
Abdominal wall
Plastic surgery
Bariatric surgery
Haemoglobin
Adult
Female
title_short Postoperative intravenously administered iron sucrose versus postoperative orally administered iron to treat post-bariatric abdominoplasty anaemia (ISAPA): the study protocol for a randomised controlled trial
title_full Postoperative intravenously administered iron sucrose versus postoperative orally administered iron to treat post-bariatric abdominoplasty anaemia (ISAPA): the study protocol for a randomised controlled trial
title_fullStr Postoperative intravenously administered iron sucrose versus postoperative orally administered iron to treat post-bariatric abdominoplasty anaemia (ISAPA): the study protocol for a randomised controlled trial
title_full_unstemmed Postoperative intravenously administered iron sucrose versus postoperative orally administered iron to treat post-bariatric abdominoplasty anaemia (ISAPA): the study protocol for a randomised controlled trial
title_sort Postoperative intravenously administered iron sucrose versus postoperative orally administered iron to treat post-bariatric abdominoplasty anaemia (ISAPA): the study protocol for a randomised controlled trial
dc.creator.none.fl_str_mv Montano-Pedroso, Juan Carlos [UNIFESP]
Garcia, Elvio Bueno [UNIFESP]
Novo, Neil Ferreira [UNIFESP]
Veiga, Daniela Francescato [UNIFESP]
Ferreira, Lydia Masako [UNIFESP]
author Montano-Pedroso, Juan Carlos [UNIFESP]
author_facet Montano-Pedroso, Juan Carlos [UNIFESP]
Garcia, Elvio Bueno [UNIFESP]
Novo, Neil Ferreira [UNIFESP]
Veiga, Daniela Francescato [UNIFESP]
Ferreira, Lydia Masako [UNIFESP]
author_role author
author2 Garcia, Elvio Bueno [UNIFESP]
Novo, Neil Ferreira [UNIFESP]
Veiga, Daniela Francescato [UNIFESP]
Ferreira, Lydia Masako [UNIFESP]
author2_role author
author
author
author
dc.subject.por.fl_str_mv Anaemia
Iron
Abdominal wall
Plastic surgery
Bariatric surgery
Haemoglobin
Adult
Female
topic Anaemia
Iron
Abdominal wall
Plastic surgery
Bariatric surgery
Haemoglobin
Adult
Female
description Background: Anaemia and iron deficiency are common complications following post-bariatric abdominoplasty. Given the low oral absorbability of iron resulting from bariatric surgery, it has been hypothesised that postoperative intravenously administered iron supplementation could be used to treat anaemia and to prevent the development of iron deficiency in these patients. Methods/Design: In this multicentre open-label randomised clinical trial, 56 adult women undergoing post-bariatric anchor-line abdominoplasty will be allocated at a ratio of 1: 1 for postoperative supplementation with two intravenously administered applications of 200 mg of iron saccharate or postoperative supplementation with 100 mg of iron polymaltose complex administered orally, twice a day for 8 weeks. The primary outcome is the difference in mean haemoglobin levels between the two groups at eight postoperative weeks. Secondary outcomes evaluated at one, four and eight postoperative weeks include iron profile, reticulocyte count, overall quality of life measured using the Short-Form 36 Health Survey (SF-36) questionnaire, fatigue measured using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F), adverse effects and postoperative complications. Discussion: This randomised clinical trial aims to evaluate the haematopoietic effectiveness of intravenously administered iron supplementation in patients undergoing post- bariatric abdominoplasty. A more effective recovery of haemoglobin levels could help improve the patients' quality of life and could provide an improved haematological status in preparation for the subsequent and frequent plastic surgeries these patients undergo.
publishDate 2016
dc.date.none.fl_str_mv 2016
2020-07-22T13:23:08Z
2020-07-22T13:23:08Z
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://dx.doi.org/10.1186/s13063-016-1300-x
Trials. London, v. 17, p. -, 2016.
10.1186/s13063-016-1300-x
WOS000373776600001.pdf
1745-6215
https://repositorio.unifesp.br/handle/11600/56053
WOS:000373776600001
dc.identifier.dark.fl_str_mv ark:/48912/001300001rzfk
url http://dx.doi.org/10.1186/s13063-016-1300-x
https://repositorio.unifesp.br/handle/11600/56053
identifier_str_mv Trials. London, v. 17, p. -, 2016.
10.1186/s13063-016-1300-x
WOS000373776600001.pdf
1745-6215
WOS:000373776600001
ark:/48912/001300001rzfk
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Trials
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv -
application/pdf
dc.coverage.none.fl_str_mv London
dc.publisher.none.fl_str_mv Biomed Central Ltd
publisher.none.fl_str_mv Biomed Central Ltd
dc.source.none.fl_str_mv reponame:Repositório Institucional da UNIFESP
instname:Universidade Federal de São Paulo (UNIFESP)
instacron:UNIFESP
instname_str Universidade Federal de São Paulo (UNIFESP)
instacron_str UNIFESP
institution UNIFESP
reponame_str Repositório Institucional da UNIFESP
collection Repositório Institucional da UNIFESP
repository.name.fl_str_mv Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP)
repository.mail.fl_str_mv biblioteca.csp@unifesp.br
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score 15.198674

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