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Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty (ISAPA)

Primary Purpose

Anemia, Iron-Deficiency, Weight Loss

Status

Completed

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Intravenous Iron sucrose

Oral Iron

About this trial

This is an interventional treatment trial for Anemia, Iron-Deficiency focused on measuring Anemia, Iron-Deficiency, bariatric surgery, abdominoplasty, surgery, plastic, iron

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Federal University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IV Iron

Oral Iron

Arm Description

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

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

Outcomes

Primary Outcome Measures

Hemoglobin level

Hemoglobin level measured at 8 postoperative weeks

Secondary Outcome Measures

Ferritin levels

FACIT

The FACIT Fatigue Scale is a health related quality of life (HRQOL) questionnaire targeted to evaluate fatigue.

SF36

Quality of Life Questionnaire

Transferrin saturation

Hemoglobin levels

Full Information

NCT ID

NCT01857011

First Posted

May 8, 2013

Last Updated

January 23, 2017

Sponsor

Federal University of São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT01857011

Brief Title

Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty

Acronym

ISAPA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

April 2014 (Actual)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of São Paulo

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia, Iron-Deficiency, Weight Loss

Keywords

Anemia, Iron-Deficiency, bariatric surgery, abdominoplasty, surgery, plastic, iron

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IV Iron

Arm Type

Experimental

Arm Description

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

Arm Title

Oral Iron

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Intravenous Iron sucrose

Other Intervention Name(s)

Noripurum

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Oral Iron

Other Intervention Name(s)

Noripurum

Intervention Description

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

Primary Outcome Measure Information:

Title

Hemoglobin level

Description

Hemoglobin level measured at 8 postoperative weeks

Time Frame

8 postoperative weeks

Secondary Outcome Measure Information:

Title

Ferritin levels

Time Frame

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

Title

FACIT

Description

The FACIT Fatigue Scale is a health related quality of life (HRQOL) questionnaire targeted to evaluate fatigue.

Time Frame

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

Title

SF36

Description

Quality of Life Questionnaire

Time Frame

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

Title

Transferrin saturation

Time Frame

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

Title

Hemoglobin levels

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juan-Carlos Montano-Pedroso, MD

Organizational Affiliation

Federal University of São Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Federal University of São Paulo

City

São Paulo

ZIP/Postal Code

04024-002

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

29958570

Citation

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.

Results Reference

derived

PubMed Identifier

27068478

Citation

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.

Results Reference

derived

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Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty

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