Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty (ISAPA)

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

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.

Study Overview

• Status: Completed
• Conditions: Anemia, Iron-Deficiency; Weight Loss
• Intervention / Treatment: Drug: Intravenous Iron sucrose; Drug: Oral Iron

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04024-002
    • Federal University of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Principal Investigator: Juan-Carlos Montano-Pedroso, MD, Federal University of São Paulo

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: May 8, 2013
• First Submitted That Met QC Criteria: May 17, 2013
• First Posted (Estimate): May 20, 2013

Study Record Updates

• Last Update Posted (Estimate): January 24, 2017
• Last Update Submitted That Met QC Criteria: January 23, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: bariatric surgery; iron; Anemia, Iron-Deficiency; abdominoplasty; surgery, plastic
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Body Weight; Anemia, Hypochromic; Iron Metabolism Disorders; Body Weight Changes; Anemia, Iron-Deficiency; Weight Loss; Anemia; Physiological Effects of Drugs; Trace Elements; Micronutrients; Hematinics; Iron; Ferric Oxide, Saccharated; Ferric Compounds; Teferrol
• Other Study ID Numbers: ISAPA UNIFESP 01