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

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

Author Montano-Pedroso, Juan Carlos Autor UNIFESP Google Scholar
Garcia, Elvio Bueno Autor UNIFESP Google Scholar
Novo, Neil Ferreira Autor UNIFESP Google Scholar
Veiga, Daniela Francescato Autor UNIFESP Google Scholar
Ferreira, Lydia Masako Autor UNIFESP Google Scholar
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.
Keywords Anaemia
Iron
Abdominal wall
Plastic surgery
Bariatric surgery
Haemoglobin
Adult
Female
xmlui.dri2xhtml.METS-1.0.item-coverage London
Language English
Sponsor Sao Paulo Research Foundation (Fundacao de Amparo a Pesquisa do Estado de Sao Paulo - FAPESP) [2014/07710-6]
Grant number FAPESP: 2014/07710-6
Date 2016
Published in Trials. London, v. 17, p. -, 2016.
ISSN 1745-6215 (Sherpa/Romeo, impact factor)
Publisher Biomed Central Ltd
Extent -
Origin http://dx.doi.org/10.1186/s13063-016-1300-x
Access rights Open access Open Access
Type Article
Web of Science ID WOS:000373776600001
URI https://repositorio.unifesp.br/handle/11600/56053

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