Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty

Study Overview
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Brief Summary
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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
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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 .

Official Title
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Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty: a Randomized Controlled Trial

Conditions
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Anemia, Iron-Deficiency, Weight Loss

Intervention / Treatment
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* Drug: Intravenous Iron sucrose
* Drug: Oral Iron


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV Iron<br>Intravenous Iron Sucrose 200 mg in the immediate postoperative period and first day postop. | Drug: Intravenous Iron sucrose<br>* Intravenous Iron Sucrose 200 mg in the immediate postoperative period and first day postop.<br>* Other names: Noripurum;|
| Active Comparator: Oral Iron<br>Oral iron(III)-hydroxide polymaltose complex 100 mg twice daily in the fist 8 postoperative weeks. | Drug: Oral Iron<br>* Oral iron(III)-hydroxide polymaltose complex 100 mg twice daily in the fist 8 postoperative weeks.<br>* Other names: Noripurum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin level | Hemoglobin level measured at 8 postoperative weeks | 8 postoperative weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ferritin levels |  | 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. | Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks | 
| SF36 | Quality of Life Questionnaire | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Iron-Deficiency, bariatric surgery, abdominoplasty, surgery, plastic, iron