Anemia, Iron-Deficiency, Weight Loss
Conditions
Keywords
Anemia, Iron-Deficiency, bariatric surgery, abdominoplasty, surgery, plastic, iron
Brief summary
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.
Detailed description
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 .
Interventions
Intravenous Iron Sucrose 200 mg in the immediate postoperative period and first day postop.
DRUGOral Iron
Oral iron(III)-hydroxide polymaltose complex 100 mg twice daily in the fist 8 postoperative weeks.
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Women * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin level | 8 postoperative weeks | Hemoglobin level measured at 8 postoperative weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The FACIT Fatigue Scale is a health related quality of life (HRQOL) questionnaire targeted to evaluate fatigue. |
| SF36 | Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks | Quality of Life Questionnaire |
| 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 | — |
Countries
Brazil
Outcome results
None listed