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Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty (ISAPA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01857011
First Posted: May 20, 2013
Last Update Posted: January 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Juan Carlos Montano Pedroso, Federal University of São Paulo
  Purpose
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.

Condition Intervention Phase
Anemia, Iron-Deficiency Weight Loss Drug: Intravenous Iron sucrose Drug: Oral Iron Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Juan Carlos Montano Pedroso, Federal University of São Paulo:

Primary Outcome Measures:
  • Hemoglobin level [ Time Frame: 8 postoperative weeks ]
    Hemoglobin level measured at 8 postoperative weeks


Secondary Outcome Measures:
  • Ferritin levels [ Time Frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks ]
  • FACIT [ 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.

  • SF36 [ Time Frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks ]
    Quality of Life Questionnaire

  • Transferrin saturation [ Time Frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks ]
  • Hemoglobin levels [ Time Frame: preoperative (one day before surgery) and 1, 4 postoperative weeks ]

Enrollment: 56
Actual Study Start Date: April 2014
Study Completion Date: June 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Noripurum

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857011


Locations
Brazil
Federal University of São Paulo
São Paulo, Brazil, 04024-002
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Juan-Carlos Montano-Pedroso, MD Federal University of São Paulo
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Juan Carlos Montano Pedroso, MD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01857011     History of Changes
Other Study ID Numbers: ISAPA UNIFESP 01
First Submitted: May 8, 2013
First Posted: May 20, 2013
Last Update Posted: January 24, 2017
Last Verified: January 2017

Keywords provided by Juan Carlos Montano Pedroso, Federal University of São Paulo:
Anemia, Iron-Deficiency
bariatric surgery
abdominoplasty
surgery, plastic
iron

Additional relevant MeSH terms:
Anemia
Weight Loss
Anemia, Iron-Deficiency
Hematologic Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Ferric oxide, saccharated
Teferrol
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics