Federal University of São Paulo
São Paulo, 04024-002, Brazil
NCT Number: NCT01857011
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.
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Notify Me18 year–55 year
Female
Interventional
Phase 3
São Paulo, 04024-002, Brazil
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 .
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous Iron Sucrose 200 mg in the immediate postoperative period and first day postop.
Other names: Noripurum
Oral iron(III)-hydroxide polymaltose complex 100 mg twice daily in the fist 8 postoperative weeks.
Other names: Noripurum
Time frame: 8 postoperative weeks
Hemoglobin level measured at 8 postoperative weeks
Time frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks
Time frame: 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.
Time frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks
Quality of Life Questionnaire
Time frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks
Time frame: preoperative (one day before surgery) and 1, 4 postoperative weeks
Federal University of São Paulo
Other
Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty: a Randomized Controlled Trial
Acronym: ISAPA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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