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

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dc.contributor.author Montano-Pedroso, Juan Carlos [UNIFESP]
dc.contributor.author Garcia, Elvio Bueno [UNIFESP]
dc.contributor.author Novo, Neil Ferreira [UNIFESP]
dc.contributor.author Veiga, Daniela Francescato [UNIFESP]
dc.contributor.author Ferreira, Lydia Masako [UNIFESP]
dc.date.accessioned 2020-07-22T13:23:08Z
dc.date.available 2020-07-22T13:23:08Z
dc.date.issued 2016
dc.identifier http://dx.doi.org/10.1186/s13063-016-1300-x
dc.identifier.citation Trials. London, v. 17, p. -, 2016.
dc.identifier.issn 1745-6215
dc.identifier.uri https://repositorio.unifesp.br/handle/11600/56053
dc.description.abstract 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. en
dc.description.sponsorship Sao Paulo Research Foundation (Fundacao de Amparo a Pesquisa do Estado de Sao Paulo - FAPESP) [2014/07710-6]
dc.format.extent -
dc.language.iso eng
dc.publisher Biomed Central Ltd
dc.relation.ispartof Trials
dc.rights Acesso aberto
dc.subject Anaemia en
dc.subject Iron en
dc.subject Abdominal wall en
dc.subject Plastic surgery en
dc.subject Bariatric surgery en
dc.subject Haemoglobin en
dc.subject Adult en
dc.subject Female en
dc.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 en
dc.type Artigo
dc.description.affiliation Univ Fed Sao Paulo, Div Plast Surg, Grad Program Translat Surg, Rua Napoleao Barros 725,4th Floor,Vila Clementino, BR-04024002 Sao Paulo, SP, Brazil
dc.description.affiliationUnifesp Univ Fed Sao Paulo, Div Plast Surg, Grad Program Translat Surg, Rua Napoleao Barros 725,4th Floor,Vila Clementino, BR-04024002 Sao Paulo, SP, Brazil
dc.description.sponsorshipID FAPESP: 2014/07710-6
dc.identifier.file WOS000373776600001.pdf
dc.identifier.doi 10.1186/s13063-016-1300-x
dc.description.source Web of Science
dc.identifier.wos WOS:000373776600001
dc.coverage London
dc.citation.volume 17



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