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

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

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 .

Keywords: Abdominal wall; Adult; Anaemia; Bariatric surgery; Female; Haemoglobin; Iron; Plastic surgery.

Figures

Fig. 1
Fig. 1
Trial flow diagram

References

    1. Ng M, Fleming T, Robinson M, Thomson B, Graetz N, Margono C, et al. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980–2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014;384:766–81. doi: 10.1016/S0140-6736(14)60460-8.
    1. Gloy VL, Briel M, Bhatt DL, Kashyap SR, Schauer PR, Mingrone G, et al. Bariatric surgery versus non-surgical treatment for obesity: a systematic review and meta-analysis of randomised controlled trials. BMJ. 2013;347:f5934. doi: 10.1136/bmj.f5934.
    1. Lim SS, Vos T, Flaxman AD, Danaei G, Shibuya K, Adair-Rohani H, et al. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380:2224–60. doi: 10.1016/S0140-6736(12)61766-8.
    1. Giordano S, Victorzon M, Koskivuo I, Suominen E. Physical discomfort due to redundant skin in post-bariatric surgery patients. J Plast Reconstr Aesthet Surg. 2013;66:950–5. doi: 10.1016/j.bjps.2013.03.016.
    1. Kitzinger HB, Abayev S, Pittermann A, Karle B, Bohdjalian A, Langer FB, et al. After massive weight loss: patients’ expectations of body contouring surgery. Obes Surg. 2012;22:544–8. doi: 10.1007/s11695-011-0551-6.
    1. Song AY, Rubin JP, Thomas V, Dudas JR, Marra KG, Fernstrom MH. Body image and quality of life in post massive weight loss body contouring patients. Obesity. 2006;14:1626–36. doi: 10.1038/oby.2006.187.
    1. Fraccalvieri M, Datta G, Bogetti P, Verna G, Pedrale R, Bocchiotti MA, et al. Abdominoplasty after weight loss in morbidly obese patients: a 4-year clinical experience. Obes Surg. 2007;17:1319–24. doi: 10.1007/s11695-007-9235-7.
    1. Borud LJ, Warren AG. Body contouring in the postbariatric surgery patient. J Am Coll Surg. 2006;203:82–93. doi: 10.1016/j.jamcollsurg.2006.01.015.
    1. Hasanbegovic E, Sørensen JA. Complications following body contouring surgery after massive weight loss: a meta-analysis. J Plast Reconstr Aesthet Surg. 2014;67:295–301. doi: 10.1016/j.bjps.2013.10.031.
    1. Obinwanne KM, Fredrickson KA, Mathiason MA, Kallies KJ, Farnen JP, Kothari SN. Incidence, treatment, and outcomes of iron deficiency after laparoscopic Roux-en-Y gastric bypass: a 10-year analysis. J Am Coll Surg. 2014;218:246–52. doi: 10.1016/j.jamcollsurg.2013.10.023.
    1. Cable CT, Colbert CY, Showalter T, Ahluwalia R, Song J, Whitfield P, et al. Prevalence of anemia after Roux-en-Y gastric bypass surgery: what is the right number? Surg Obes Relat Dis. 2010;7:134–9. doi: 10.1016/j.soard.2010.10.013.
    1. Love AL, Billett HH. Obesity, bariatric surgery, and iron deficiency: true, true, true and related. Am J Hematol. 2008;83:403–9. doi: 10.1002/ajh.21106.
    1. Montano-Pedroso JC, Garcia EB, Omonte IRV, Rocha MGC, Ferreira LM. Hematological variables and iron status in abdominoplasty after bariatric surgery. Obes Surg. 2013;23:7–16. doi: 10.1007/s11695-012-0720-2.
    1. Davison SP, Clemens MW. Safety first: precautions for the massive weight loss patient. Clin Plast Surg. 2008;35:173–83. doi: 10.1016/j.cps.2007.08.002.
    1. Marik PE, Corwin HL. Efficacy of red blood cell transfusion in the critically ill: a systematic review of the literature. Crit Care Med. 2008;36:2667–74. doi: 10.1097/CCM.0b013e3181844677.
    1. Hopewell S, Omar O, Hyde C, Yu L-M, Doree C, Murphy MF. A systematic review of the effect of red blood cell transfusion on mortality: evidence from large-scale observational studies published between 2006 and 2010. BMJ Open. 2013;3:e002154.
    1. Isbister JP, Shander A, Spahn DR, Erhard J, Farmer SL, Hofmann A. Adverse blood transfusion outcomes: establishing causation. Transfus Med Rev. 2011;25:89–101. doi: 10.1016/j.tmrv.2010.11.001.
    1. Masoomi H, Rimler J, Wirth GA, Paydar KZ, Evans GRD, Aly A. Frequency and risk factors of blood transfusion in abdominoplasty in post-bariatric surgery patients. Plast Reconstr Surg. 2014;134:105–6. doi: 10.1097/01.prs.0000455462.24313.f5.
    1. Hare GMT, Freedman J, David MC. Review article: risks of anemia and related management strategies: can perioperative blood management improve patient safety? Can J Anesth. 2013;60:168–75. doi: 10.1007/s12630-012-9861-y.
    1. Nelson JA, Fischer JP, Chung CU, Fosnot J, Selber JC, Serletti JM, et al. Preoperative anemia impacts early postoperative recovery following autologous breast reconstruction. J Plast Reconstr Aesthet Surg. 2014;67:797–803. doi: 10.1016/j.bjps.2014.02.017.
    1. Nelson JA, Fischer JP, Grover R, Cleveland E, Erdmann-Sager J, Serletti JM, et al. The impact of anemia on microsurgical breast reconstruction complications and outcomes. Microsurgery. 2014;34:261–70. doi: 10.1002/micr.22202.
    1. Baron DM, Hochrieser H, Posch M, Metnitz B, Rhodes A, Moreno RP, et al. Preoperative anaemia is associated with poor clinical outcome in non-cardiac surgery patients. Br J Anaesth. 2014;113:416–23. doi: 10.1093/bja/aeu098.
    1. Carson JL, Terrin ML, Magaziner J. Anemia and postoperative rehabilitation. Can J Anaesth. 2003;50(6 Suppl):S60–4.
    1. Wallach SG. Abdominal contour surgery for the massive weight loss patient: the fleur-de-lis approach. Aesthet Surg J. 2005;25:454–65. doi: 10.1016/j.asj.2005.06.001.
    1. Patterson AJ, Brown WJ, Roberts DC. Dietary and supplement treatment of iron deficiency results in improvements in general health and fatigue in Australian women of childbearing age. J Am Coll Nutr. 2001;20:337–42. doi: 10.1080/07315724.2001.10719054.
    1. Verdon F, Burnand B, Stubi C-LF, Bonard C, Graff M, Michaud A, et al. Iron supplementation for unexplained fatigue in non-anaemic women: double blind randomised placebo controlled trial. BMJ. 2003;326:1124. doi: 10.1136/bmj.326.7399.1124.
    1. Krayenbuehl P-A, Battegay E, Breymann C, Furrer J, Schulthess G. Intravenous iron for the treatment of fatigue in nonanemic, premenopausal women with low serum ferritin concentration. Blood. 2011;118:3222–7. doi: 10.1182/blood-2011-04-346304.
    1. Kleinert K, Theusinger OM, Nuernberg J, Werner CML. Alternative procedures for reducing allogeneic blood transfusion in elective orthopedic surgery. HSS J. 2010;6:190–8. doi: 10.1007/s11420-009-9151-6.
    1. Auerbach M, Ballard H, Glaspy J. Clinical update: intravenous iron for anaemia. Lancet. 2007;369:1502–4. doi: 10.1016/S0140-6736(07)60689-8.
    1. Critchley J, Dundar Y. Adverse events associated with intravenous iron infusion (low-molecular-weight iron dextran and iron sucrose): a systematic review. Transfus Altern Transfus Med. 2007;9:8–36. doi: 10.1111/j.1778-428X.2007.00042.x.
    1. Muñoz M, Gómez-Ramírez S, Cuenca J, García-Erce JA, Iglesias-Aparicio D, Haman-Alcober S, et al. Very-short-term perioperative intravenous iron administration and postoperative outcome in major orthopedic surgery: a pooled analysis of observational data from 2547 patients. Transfusion. 2014;54:289–99.
    1. Yoon HM, Kim YW, Nam BH, Reim D, Eom BW, Park JY, et al. Intravenous iron supplementation may be superior to observation in acute isovolemic anemia after gastrectomy for cancer. World J Gastroenterol. 2014;20:1852–7. doi: 10.3748/wjg.v20.i7.1852.
    1. Armand-Ugón R, Cheong T, Matapandewu G, Rojo-Sanchís A, Bisbe E, Muñoz M. Efficacy of intravenous iron for treating postpartum anemia in low-resource African countries: a pilot study in Malawi. J Womens Health (Larchmt) 2011;20:123–7. doi: 10.1089/jwh.2010.2192.
    1. Mudge DW, Tan K-S, Miles R, Johnson DW, Campbell SB, Hawley CM, et al. Intravenous versus oral iron supplementation for correction of post-transplant anaemia in renal transplant patients. BMC Nephrol. 2009;10:14. doi: 10.1186/1471-2369-10-14.
    1. Rozen-Zvi B, Gafter-Gvili A, Zingerman B, Levy-Drummer RS, Levy L, Mor E, et al. Intravenous iron supplementation after kidney transplantation. Clin Transplant. 2012;26:608–14. doi: 10.1111/j.1399-0012.2012.01602.x.
    1. Beguin Y, Jaspers A. Iron sucrose – characteristics, efficacy and regulatory aspects of an established treatment of iron deficiency and iron-deficiency anemia in a broad range of therapeutic areas. Expert Opin Pharmacother. 2014;15:2087–103. doi: 10.1517/14656566.2014.953928.
    1. Gurusamy KS, Nagendran M, Broadhurst JF, Anker SD, Richards T. Iron therapy in anaemic adults without chronic kidney disease. Cochrane Database Syst Rev. 2014;12:CD010640.
    1. Varma S, Baz W, Badine E, Nakhl F, McMullen H, Nicastro J, et al. Need for parenteral iron therapy after bariatric surgery. Surg Obes Relat Dis. 2008;4:715–9. doi: 10.1016/j.soard.2008.04.015.
    1. DeFilipp Z, Lister J, Gagné D, Shadduck RK, Prendergast L, Kennedy M. Intravenous iron replacement for persistent iron deficiency anemia after Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2013;9:129–32. doi: 10.1016/j.soard.2012.06.007.
    1. Malone M, Alger-Mayer S, Lindstrom J, Bailie GR. Management of iron deficiency and anemia after Roux-en-Y gastric bypass surgery: an observational study. Surg Obes Relat Dis. 2013;9:969–74. doi: 10.1016/j.soard.2013.01.019.
    1. Song AY, Jean RD, Hurwitz DJ, Fernstrom MH, Scott JA, Rubin JP. A classification of contour deformities after bariatric weight loss: the Pittsburgh Rating Scale. Plast Reconstr Surg. 2005;116:1535–44. doi: 10.1097/01.prs.0000182606.92069.13.
    1. Costa LF, Landecker A, Manta AM. Optimizing body contour in massive weight loss patients: the modified vertical abdominoplasty. Plast Reconstr Surg. 2004;114:1917–23. doi: 10.1097/01.PRS.0000142997.63346.95.
    1. Figueiredo AEPL. O papel da enfermagem na administração do ferro por via parenteral. Rev Bras Hematol Hemoter. 2010;32:129–33. doi: 10.1590/S1516-84842010005000068.
    1. Cançado RD, Lobo C, Friedrich JR. Tratamento da anemia ferropriva com ferro por via parenteral. Rev Bras Hematol Hemoter. 2010;32:121–8. doi: 10.1590/S1516-84842010005000066.
    1. Nieuwlaat R, Wilczynski N, Navarro T, Hobson N, Jeffery R, Keepanasseril A, et al. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2014;11:CD000011.
    1. Ben AJ, Neumann CR, Mengue SS. Teste de Morisky-Green e Brief Medication Questionnaire para avaliar adesão a medicamentos. Rev Saude Publica. 2012;46:279–89. doi: 10.1590/S0034-89102012005000013.
    1. Stewart K, Mc Namara KP, George J. Challenges in measuring medication adherence: Experiences from a controlled trial. Int J Clin Pharm. 2014;36:15–9. doi: 10.1007/s11096-013-9877-6.
    1. Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986;24:67–74. doi: 10.1097/00005650-198601000-00007.
    1. Haynes RB, Taylor DW, Sackett DL, Gibson ES, Bernholz CD, Mukherjee J. Can simple clinical measurements detect patient noncompliance? Hypertension. 1980;2:757–64. doi: 10.1161/01.HYP.2.6.757.
    1. Santa Helena ET, Nemes MIB, Eluf-Neto J. Desenvolvimento e validação de questionário multidimensional para medir não-adesão ao tratamento com medicamentos. Rev Saude Publica. 2008;42:764–7. doi: 10.1590/S0034-89102008000400025.
    1. Carless PA, Henry DA, Carson JL, Hebert PP, McClelland B, Ker K. Transfusion thresholds and other strategies for guiding allogeneic red blood cell transfusion. Cochrane Database Syst Rev. 2010;10:CD002042.
    1. Ciconelli RM, Ferraz MB, Santos W, Meinão I, Quaresma MR. Tradução para a língua portuguesa e validação do questionário genérico de avaliação de qualidade de vida SF-36 (Brasil SF-36) Rev Bras Reum. 1999;39:143–50.
    1. Ishikawa NM, Thuler LCS, Giglio AG, Da Rocha Baldotto CS, De Andrade CJC, Derchain SFM. Validation of the Portuguese version of Functional Assessment of Cancer Therapy-Fatigue (FACT-F) in Brazilian cancer patients. Support Care Cancer. 2010;18:481–90. doi: 10.1007/s00520-009-0697-0.
    1. National Cancer Institute. Common terminology criteria for adverse events (CTCAE). NIH publication #09–7473. Bethesda, MD: National Cancer Institute; 2009.
    1. Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol. 1992;13:606–8. doi: 10.1017/S0195941700015241.
    1. Stannard JP, Volgas DA, McGwin G, Stewart RL, Obremskey W, Moore T, et al. Incisional negative pressure wound therapy after high-risk lower extremity fractures. J Orthop Trauma. 2012;26:37–42. doi: 10.1097/BOT.0b013e318216b1e5.
    1. Freudenheim JL. A review of study designs and methods of dietary assessment in nutritional epidemiology of chronic disease. J Nutr. 1993;123(2 Suppl):401–5.
    1. Cameron ME, Van Staveren WA. Manual on methodology for food consumption studies. Oxford: Oxford University Press; 1988.
    1. Anção MS, Cuppari L, Draibe AS, Sigulem D. Programa de apoio à nutrição Nutwin: versão 1.5. SPDM: Sao Paulo; 2002.
    1. Savaris RF, Braun RD. Menorrhagia and hemoglobin levels. Int J Gynecol Obstet. 2007;97:199–200. doi: 10.1016/j.ijgo.2007.02.013.
    1. Suljević E, Fazlić M, Corić J, Kiseljaković JC. Evaluation of haematology analyzer CELL-DYN 3700 SL. Bosn J Basic Med Sci. 2003;3:35–41.
    1. Potgieter MA, Potgieter JH, Venter C, Venter JL, Geisser P. Effect of oral aluminium hydroxide on iron absorption from iron(III)-hydroxide polymaltose complex in patients with iron deficiency anemia/a single-centre randomized controlled isotope study. Arzneimittelforschung. 2007;57:392–400.
    1. Kallich J, McDermott A, Xu X, Fayers P, Cella D. The relationship between patient knowledge of hemoglobin levels and health-related quality of life. Qual Life Res. 2006;15:57–68. doi: 10.1007/s11136-005-8324-0.
    1. Elliott AC, Hynan LS, Reisch JS, Smith JP. Preparing data for analysis using Microsoft Excel. J Investig Med. 2006;54:334–41. doi: 10.2310/6650.2006.05038.
    1. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. J Pharmacol Pharmacother. 2010;1:42–58.
    1. Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi: 10.1136/bmj.e7586.
    1. Holm C, Thomsen LL, Norgaard A, Langhoff-Roos J. Intravenous iron isomaltoside 1000 administered by high single-dose infusions or standard medical care for the treatment of fatigue in women after postpartum haemorrhage: study protocol for a randomised controlled trial. Trials. 2015;16:5. doi: 10.1186/1745-6215-16-5.
    1. Bucher HC, Guyatt G, Cook D, Holbrook A, McAlister FAF. Users’ guides to the medical literature: XIX. Applying clinical trial results: A. How to use an article measuring the effect of an intervention on surrogate end points. JAMA. 1999;282:771–8. doi: 10.1001/jama.282.8.771.
    1. Gandra SR, Finkelstein FO, Bennett AV, Lewis EF, Brazg T, Martin ML. Impact of erythropoiesis-stimulating agents on energy and physical function in nondialysis CKD patients with anemia: a systematic review. Am J Kidney Dis. 2010;55:519–34. doi: 10.1053/j.ajkd.2009.09.019.
    1. Bjorner JB, Wallenstein GV, Martin MC, Lin P, Blaisdell-Gross B, Tak Piech C, et al. Interpreting score differences in the SF-36 Vitality scale: using clinical conditions and functional outcomes to define the minimally important difference. Curr Med Res Opin. 2007;23:731–9. doi: 10.1185/030079907X178757.
    1. Reim D, Kim Y-W, Nam B, Kim M-J, Yook J, Park Y, et al. FAIRY: a randomized controlled patient-blind phase III study to compare the efficacy and safety of intravenous ferric carboxymaltose (Ferinject®) to placebo in patients with acute isovolemic anemia after gastrectomy – study protocol for a randomized controlled trial. Trials. 2014;15:111. doi: 10.1186/1745-6215-15-111.
    1. Wallis JP, Wells AW, Whitehead S, Brewster N. Recovery from post-operative anaemia. Transfus Med. 2005;15:413–8. doi: 10.1111/j.1365-3148.2005.00607.x.
    1. Biesma DH, Van de Wiel A, Beguin Y, Kraaijenhagen RJ, Marx JJ. Post-operative erythropoiesis is limited by the inflammatory effect of surgery on iron metabolism. Eur J Clin Invest. 1995;25:383–9. doi: 10.1111/j.1365-2362.1995.tb01718.x.
    1. Varadhan KK, Lobo DN, Ljungqvist O. Enhanced recovery after surgery: the future of improving surgical care. Crit Care Clin. 2010;26:527–47. doi: 10.1016/j.ccc.2010.04.003.
    1. Richards T, Clevenger B, Keidan J, Collier T, Klein AA, Anker SD, et al. PREVENTT: preoperative intravenous iron to treat anaemia in major surgery: study protocol for a randomised controlled trial. Trials. 2015;16:254. doi: 10.1186/s13063-015-0774-2.
    1. Hofmann A, Farmer S, Shander A. Five drivers shifting the paradigm from product-focused transfusion practice to patient blood management. Oncologist. 2011;16(Suppl 3):3–11. doi: 10.1634/theoncologist.2011-S3-3.

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