Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty

Federal University of São Paulo56 enrolled

Overview

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.

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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Anemia, Iron-Deficiency Weight Loss

Interventions

Intravenous Iron sucroseDRUG

Intravenous Iron Sucrose 200 mg in the immediate postoperative period and first day postop.

Oral IronDRUG

Oral iron(III)-hydroxide polymaltose complex 100 mg twice daily in the fist 8 postoperative weeks.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Federal University of São Paulo

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

Hemoglobin level

Hemoglobin level measured at 8 postoperative weeks

Time frame: 8 postoperative weeks

Secondary Outcomes

Ferritin levels

Time frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks

FACIT

The FACIT Fatigue Scale is a health related quality of life (HRQOL) questionnaire targeted to evaluate fatigue.

Time frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks

SF36

Quality of Life Questionnaire

Time frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks

Transferrin saturation

Time frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks

Hemoglobin levels

Time frame: preoperative (one day before surgery) and 1, 4 postoperative weeks

Data from ClinicalTrials.gov

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