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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

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

Authors: Juan Carlos Montano-Pedroso, Elvio Bueno Garcia, Neil Ferreira Novo, Daniela Francescato Veiga, Lydia Masako Ferreira

Published in: Trials | Issue 1/2016

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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.

Trial registration

Clinicaltrials.gov Identifier: NCT01857011 (8 May 2013), Universal Trial Number U111-1169-6223, Brazilian Clinical Trials Registry (REBEC): RBR-2JGRKQ.
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Metadata
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
Authors
Juan Carlos Montano-Pedroso
Elvio Bueno Garcia
Neil Ferreira Novo
Daniela Francescato Veiga
Lydia Masako Ferreira
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1300-x

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