Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Hemoglobin level
研究概览
简要总结
The purpose of this study is to determine whether intravenous or oral iron are effective in the treatment of postoperative anemia and iron deficiency in patients submitted in postbariatric abdominoplasty.
详细描述
Multicenter open randomized clinical trial with allocation ratio 1: 1. 56 adult patients undergoing post- bariatric abdominoplasty will be evaluated. The study group will receive 200 mg of intravenous iron in the immediate postoperative period and a second application on day 1 postoperatively. The control group will receive 100 mg of oral iron twice daily for 8 weeks. Haematological variables , iron 's profile , quality of life ( SF -36 and FACT- An) and adverse events will be assessed preoperatively and on the first , fourth and eighth weeks postoperatively .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 a 55 years
- •Prior open or laparoscopic standard limb Roux and Y gastric bypass
- •BMI < 32 kg/m2
- •Stability of weight loss for at least 6 months
- •grade 3 abdominal deformity on the Pittsburgh scale
排除标准
- •Illiterate
- •Current smoking
- •Prior IV iron use in the last 3 months
- •Uncontrolled systemic diseases
- •Hemoglobin < 11 g/dL
- •Ferritin <11 ng/mL
- •Ferritin > 100 ng/mL
- •transferrin saturation <16%
- •transferrin saturation> 50%
- •B12 < 210 pg/mL
- •Folic Acid < 3.3 ng/mL
- •Albumin < 2 g/dL
- •C reactive protein> 5 mg/L
- •Prior Anaphylactic reaction to IV iron
研究组 & 干预措施
IV Iron
Intravenous Iron Sucrose 200 mg in the immediate postoperative period and first day postop.
干预措施: Intravenous Iron sucrose (Drug)
Oral Iron
Oral iron(III)-hydroxide polymaltose complex 100 mg twice daily in the fist 8 postoperative weeks.
干预措施: Oral Iron (Drug)
结局指标
主要结局
Hemoglobin level
时间窗: 8 postoperative weeks
Hemoglobin level measured at 8 postoperative weeks
次要结局
- Ferritin levels(Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks)
- FACIT(Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks)
- SF36(Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks)
- Transferrin saturation(Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks)
- Hemoglobin levels(preoperative (one day before surgery) and 1, 4 postoperative weeks)
研究者
Juan Carlos Montano Pedroso
MD
Federal University of São Paulo