NCT01857011

Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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 .

Conditions

• Anemia, Iron-Deficiency
• Weight Loss

Interventions

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

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-04-01
• Completion: 2016-06-01
• First posted: 2013-05-20
• Last updated: 2017-01-24

Locations

1 site across 1 country: Brazil