Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty (ISAPA)

Federal University of São Paulo

Status and phase: Completed; Phase 3

Conditions: Weight Loss; Anemia, Iron-Deficiency

Treatments: Drug: Intravenous Iron sucrose; Drug: Oral Iron

Study type: Interventional

Funder types: Other

Identifiers

NCT01857011

ISAPA UNIFESP 01

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 56 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

IV Iron

Experimental group

Description:

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

Treatment:

Drug: Intravenous Iron sucrose

Oral Iron

Active Comparator group

Description:

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

Treatment:

Drug: Oral Iron