NCT01857011

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 20, 2013

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

May 8, 2013

Last Update Submit

January 23, 2017

Conditions

Anemia, Iron-DeficiencyWeight Loss

Keywords

Anemia, Iron-Deficiencybariatric surgeryabdominoplastysurgery, plasticiron

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin level

    Hemoglobin level measured at 8 postoperative weeks

    8 postoperative weeks

Secondary Outcomes (5)

  • Ferritin levels

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

  • FACIT

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

  • SF36

    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

Study Arms (2)

IV Iron

EXPERIMENTAL

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

Drug: Intravenous Iron sucrose

Oral Iron

ACTIVE COMPARATOR

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

Drug: Oral Iron

Interventions

Intravenous Iron sucroseDRUG

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

Also known as: Noripurum
IV Iron
Oral IronDRUG

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

Also known as: Noripurum
Oral Iron

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 04024-002, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 29958570DERIVED

  • 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.

    PMID: 27068478DERIVED

MeSH Terms

Conditions

Anemia, Iron-DeficiencyWeight Loss

Interventions

teferrolIron

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Juan-Carlos Montano-Pedroso, MD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 8, 2013

First Posted

May 20, 2013

Study Start

April 1, 2014

Primary Completion

April 1, 2016

Study Completion

June 1, 2016

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

BR(1)