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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinicaltrials.gov Identifier: NCT01857011 (8 May 2013), Universal Trial Number U111-1169-6223, Brazilian Clinical Trials Registry (REBEC): RBR-2JGRKQ .
authors.affiliation: Division of Plastic Surgery, Graduate Program in Translational Surgery, Federal University of São Paulo, Rua Napoleão de Barros, 725, 4th Floor, Vila Clementino, CEP: 04024-002, São Paulo, SP, Brazil. juancmontano@gmail.com.
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Montano-Pedroso
authors.affiliation: Division of Plastic Surgery, Graduate Program in Translational Surgery, Federal University of São Paulo, Rua Napoleão de Barros, 725, 4th Floor, Vila Clementino, CEP: 04024-002, São Paulo, SP, Brazil.
authors.forename: Elvio Bueno
authors.initials: EB
authors.lastname: Garcia
authors.affiliation: Division of Plastic Surgery, Graduate Program in Translational Surgery, Federal University of São Paulo, Rua Napoleão de Barros, 725, 4th Floor, Vila Clementino, CEP: 04024-002, São Paulo, SP, Brazil.
authors.forename: Neil Ferreira
authors.initials: NF
authors.lastname: Novo
authors.affiliation: Division of Plastic Surgery, Graduate Program in Translational Surgery, Federal University of São Paulo, Rua Napoleão de Barros, 725, 4th Floor, Vila Clementino, CEP: 04024-002, São Paulo, SP, Brazil.
authors.forename: Daniela Francescato
authors.initials: DF
authors.lastname: Veiga
authors.affiliation: Division of Plastic Surgery, Graduate Program in Translational Surgery, Federal University of São Paulo, Rua Napoleão de Barros, 725, 4th Floor, Vila Clementino, CEP: 04024-002, São Paulo, SP, Brazil.
authors.forename: Lydia Masako
authors.initials: LM
authors.lastname: Ferreira
mesh_terms: D061645:Abdominoplasty / Q000009:adverse effects*; D061605:Administration, Intravenous; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000740:Anemia / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D050110:Bariatric Surgery; D015415:Biomarkers / Q000097:blood; D001938:Brazil; D002985:Clinical Protocols; D004334:Drug Administration Schedule; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid / Q000008:administration & dosage* / Q000009:adverse effects; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects; D006410:Hematopoiesis / Q000187:drug effects*; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D008875:Middle Aged; D011788:Quality of Life; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D015415:Biomarkers; D005290:Ferric Compounds; D006397:Hematinics; D006454:Hemoglobins; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid; C013276:teferrol
keywords: Abdominal wall; Adult; Anaemia; Bariatric surgery; Female; Haemoglobin; Iron; Plastic surgery