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Completed

NCT Number: NCT01857011

Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty

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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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Federal University of São Paulo

São Paulo, 04024-002, Brazil

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous Iron Sucrose

Drug

Intravenous Iron Sucrose 200 mg in the immediate postoperative period and first day postop.

Other names: Noripurum

oral iron

Drug

Oral iron(III)-hydroxide polymaltose complex 100 mg twice daily in the fist 8 postoperative weeks.

Other names: Noripurum

Primary outcomes

  1. Hemoglobin level

    Time frame: 8 postoperative weeks

    Hemoglobin level measured at 8 postoperative weeks

Secondary outcomes

  1. Ferritin levels

    Time frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks

  2. 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.

  3. SF36

    Time frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks

    Quality of Life Questionnaire

  4. Transferrin saturation

    Time frame: Preoperative (one day before surgery) and 1, 4 and 8 postoperative weeks

  5. Hemoglobin levels

    Time frame: preoperative (one day before surgery) and 1, 4 postoperative weeks

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Acronym: ISAPA

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 20, 2013
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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