Montano-Pedroso Juan Carlos, Bueno Garcia Elvio, Alcântara Rodrigues de Moraes Mariana, Francescato Veiga Daniela, Masako Ferreira Lydia
Division of Plastic Surgery, Graduate Program in Translational Surgery, Federal University of São Paulo-UNIFESP, São Paulo, SP, Brazil.
Division of Plastic Surgery, Graduate Program in Translational Surgery, Federal University of São Paulo-UNIFESP, São Paulo, SP, Brazil.
Lancet Haematol. 2018 Jul;5(7):e310-e320. doi: 10.1016/S2352-3026(18)30071-1.
Anaemia and iron deficiency are common after post-bariatric abdominoplasty, which can involve removal of large areas of skin with associated blood loss. Because the oral absorbability of iron is reduced after bariatric surgery (through reduced intake, reduction of gastric acid secretion for conjugation of iron, and separation of the iron-absorptive areas of the duodenum and jejunum), it has been hypothesised that postoperative intravenous iron supplementation might be used to treat anaemia and iron deficiency in patients submitted to post-bariatric plastic surgeries. We aimed to assess whether intravenous iron administered postoperatively in post-bariatric abdominoplasty could result in increased blood haemoglobin concentrations compared with oral iron supplementation.
In this open-label, randomised, superiority trial, we recruited women aged 18-55 years undergoing post-bariatric abdominoplasty at two public tertiary referral hospitals in São Paulo, Brazil. Eligible women had been treated for previous obesity with bariatric surgery using the vertical banded gastroplasty technique with Roux-en-Y gastric bypass by laparotomy; had grade III contour deformity via the Pittsburgh rating scale; and had a post-bariatric body-mass index (BMI) lower than 32 kg/m, with stabilised weight loss for at least 6 months. Women were randomly assigned (1:1) to receive postoperative iron supplementation with two intravenous infusions of 200 mg of iron sucrose (intravenous group) or 100 mg of iron polymaltose complex orally twice a day for 8 weeks (oral group). The primary outcome in both groups was blood haemoglobin concentration at postoperative day 56 after abdominoplasty, with a minimum clinically relevant difference of 1·5 g/dL. Analyses were performed on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT01857011, and the Brazilian Clinical Trials Registry, number RBR-2JGRKQ. The trial is completed.
From April 7, 2014, to June 27, 2016, 102 post-bariatric patients were assessed for eligibility. 56 patients were eligible and were randomly assigned, with 28 allocated to each group. Mean baseline haemoglobin concentration was slightly higher in the oral group than in the intravenous group (12·71 g/dL [SD 1·06] vs 12·24 g/L [1·09]), and by post-operative day 56 was 12·54 g/dL (SD 1·18) and 12·80 g/dL (0·81), respectively (mean difference of 0·26 g/dL, 95% CI -0·28 to 0·80; p=0·009 in favour of the intravenous group). The minimum clinically relevant difference in concentrations was not reached. No adverse events were recorded in the intravenous group, whereas in the oral group, constipation was recorded in five (18%) patients, diarrhoea in three (11%), and nausea in one (4%) patient.
Postoperative intravenous administration of iron increased haemoglobin concentrations at 56 days post-operatively and reduced iron deficiency, without adverse events. Although superiority of intravenous iron was not shown, intravenous administration might be useful in post-bariatric patients, especially in those who have body-contouring treatment involving a second surgery within a short period of time. Larger trials, and trials using higher intravenous doses of iron, are needed to further assess the potential efficacy and safety of intravenous iron administration after post-bariatric plastic surgery.
The São Paulo Research Foundation (FAPESP).
减重术后腹壁成形术后贫血和缺铁很常见，这可能涉及大面积皮肤切除及相关失血。由于减重手术后铁的口服吸收能力下降（通过减少摄入量、减少用于铁结合的胃酸分泌以及十二指肠和空肠铁吸收区域的分离），有人推测术后静脉补充铁剂可用于治疗接受减重后整形手术患者的贫血和缺铁。我们旨在评估与口服铁补充剂相比，减重术后腹壁成形术后静脉注射铁剂是否能提高血红蛋白浓度。
在这项开放标签、随机、优效性试验中，我们招募了年龄在18至55岁之间、在巴西圣保罗的两家公立三级转诊医院接受减重术后腹壁成形术的女性。符合条件的女性此前因肥胖接受了减重手术，采用垂直束带胃成形术加Roux-en-Y胃旁路术通过剖腹手术进行治疗；根据匹兹堡评分量表为III级轮廓畸形；减重后体重指数（BMI）低于32 kg/m²，体重稳定减轻至少6个月。女性被随机分配（1:1）接受术后铁补充，静脉注射组为两次静脉输注200 mg蔗糖铁，口服组为每天口服两次100 mg聚麦芽糖铁复合物，持续8周。两组的主要结局是腹壁成形术后第56天的血红蛋白浓度，最小临床相关差异为1.5 g/dL。分析按意向性分析进行。该试验已在ClinicalTrials.gov注册，编号为NCT01857011，在巴西临床试验注册中心注册，编号为RBR-2JGRKQ。试验已完成。
从2014年4月7日至2016年6月27日，对102例减重术后患者进行了资格评估。56例患者符合条件并被随机分配，每组28例。口服组的平均基线血红蛋白浓度略高于静脉注射组（12.71 g/dL [标准差1.06] 对12.24 g/L [1.09]），到术后第56天分别为12.54 g/dL（标准差1.18）和12.80 g/dL（0.81）（平均差异0.26 g/dL，95%置信区间 -0.28至0.80；p = 0.009，支持静脉注射组）。未达到浓度的最小临床相关差异。静脉注射组未记录到不良事件，而口服组有5例（18%）患者出现便秘，3例（11%）出现腹泻，1例（4%）出现恶心。
术后静脉注射铁剂可在术后56天时提高血红蛋白浓度并减少缺铁，且无不良事件。虽然未显示静脉注射铁剂的优效性，但静脉注射可能对减重术后患者有用，尤其是那些在短时间内进行涉及二次手术的身体塑形治疗的患者。需要更大规模的试验以及使用更高静脉剂量铁剂的试验来进一步评估减重后整形手术后静脉注射铁剂的潜在疗效和安全性。
圣保罗研究基金会（FAPESP）。
