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Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty (ISAPA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Juan Carlos Montano Pedroso, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01857011
First received: May 8, 2013
Last updated: January 23, 2017
Last verified: January 2017
  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: 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 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 8, 2013
Last Updated: January 23, 2017

Keywords provided by 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

ClinicalTrials.gov processed this record on April 28, 2017