Clinical trial NCT01857011: Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty
Official title: Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia, Iron-Deficiency
Weight Loss
Keywords: Anemia, Iron-Deficiency
bariatric surgery
abdominoplasty
surgery, plastic
iron
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2013-05-20
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin level
timeFrame: 8 postoperative weeks
Secondary outcomes:
measure: Ferritin levels
timeFrame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks
measure: FACIT
timeFrame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks
measure: SF36
timeFrame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks
measure: Transferrin saturation
timeFrame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks
measure: Hemoglobin levels
timeFrame: preoperative (one day before surgery) and 1, 4 postoperative weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Juan-Carlos Montano-Pedroso, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Montano-Pedroso JC, Bueno Garcia E, Alcantara Rodrigues de Moraes M, Francescato Veiga D, Masako Ferreira L. Intravenous iron sucrose versus oral iron administration for the postoperative treatment of post-bariatric abdominoplasty anaemia: an open-label, randomised, superiority trial in Brazil. Lancet Haematol. 2018 Jul;5(7):e310-e320. doi: 10.1016/S2352-3026(18)30071-1.
citation: Montano-Pedroso JC, Garcia EB, Novo NF, Veiga DF, Ferreira LM. Postoperative intravenously administered iron sucrose versus postoperative orally administered iron to treat post-bariatric abdominoplasty anaemia (ISAPA): the study protocol for a randomised controlled trial. Trials. 2016 Apr 12;17:196. doi: 10.1186/s13063-016-1300-x.