Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty

Phase 3

Completed

• Conditions: Weight Loss; Anemia, Iron-Deficiency
• Interventions: Drug: Oral Iron; Drug: Intravenous Iron sucrose

• Registration Number: NCT01857011
• Lead Sponsor: Federal University of São Paulo

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 .

Study Timeline

• Study First Submitted: 2013-05-08
• Study First Submitted QC: 2013-05-17
• Study First Posted: 2013-05-20
• Study Start: 2014-04
• Primary Completion: 2016-04
• Study Completion: 2016-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Iron	Oral Iron	Oral iron(III)-hydroxide polymaltose complex 100 mg twice daily in the fist 8 postoperative weeks.
IV Iron	Intravenous Iron sucrose	Intravenous Iron Sucrose 200 mg in the immediate postoperative period and first day postop.

Primary Outcome Measures

Name	Time	Method
Hemoglobin level	8 postoperative weeks	Hemoglobin level measured at 8 postoperative weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Federal University of São Paulo; 🇧🇷 São Paulo, Brazil