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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
January 1, 1970
Juan Carlos Montano-Pedroso et al. (5 authors)
Comparative StudyJournal ArticleMulticenter StudyRandomized Controlled TrialResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to evaluate the effectiveness of intravenous iron supplementation versus oral iron in treating anemia and preventing iron deficiency in women undergoing post-bariatric abdominoplasty.

Results Summary

The study compared intravenous iron saccharate (two 200 mg doses) with oral iron polymaltose (100 mg twice daily for 8 weeks), measuring hemoglobin levels and iron profiles. Secondary outcomes included quality of life, fatigue, and adverse effects, but specific results were not detailed in the abstract.

Population

Adult women undergoing post-bariatric anchor-line abdominoplasty.

Effective Dosage

Intravenous iron saccharate (200 mg, two applications) or oral iron polymaltose (100 mg twice daily).

Duration

8 weeks.

Interactions

None mentioned.

Extracted Claims (14)
InterventionDirectionEndpointPopulationDosageImpactClaim #
postoperative supplementation with two intravenously administered applications of 200 mg of iron saccharate
increase
haemoglobin levels
adult women undergoing post-bariatric anchor-line abdominoplasty
-
evaluate the haematopoietic effectiveness
#1
postoperative supplementation with two intravenously administered applications of 200 mg of iron saccharate
increase
iron profile
adult women undergoing post-bariatric anchor-line abdominoplasty
-
evaluate the haematopoietic effectiveness
#2
postoperative supplementation with two intravenously administered applications of 200 mg of iron saccharate
increase
reticulocyte count
adult women undergoing post-bariatric anchor-line abdominoplasty
-
evaluate the haematopoietic effectiveness
#3
postoperative supplementation with two intravenously administered applications of 200 mg of iron saccharate
increase
overall quality of life measured using the Short-Form 36 Health Survey (SF-36) questionnaire
adult women undergoing post-bariatric anchor-line abdominoplasty
-
evaluate the haematopoietic effectiveness
#4
postoperative supplementation with two intravenously administered applications of 200 mg of iron saccharate
decrease
fatigue measured using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
adult women undergoing post-bariatric anchor-line abdominoplasty
-
evaluate the haematopoietic effectiveness
#5
postoperative supplementation with two intravenously administered applications of 200 mg of iron saccharate
neutral
adverse effects
adult women undergoing post-bariatric anchor-line abdominoplasty
-
evaluate the haematopoietic effectiveness
#6
postoperative supplementation with two intravenously administered applications of 200 mg of iron saccharate
neutral
postoperative complications
adult women undergoing post-bariatric anchor-line abdominoplasty
-
evaluate the haematopoietic effectiveness
#7
postoperative supplementation with 100 mg of iron polymaltose complex administered orally, twice a day for 8 weeks
increase
haemoglobin levels
adult women undergoing post-bariatric anchor-line abdominoplasty
-
evaluate the haematopoietic effectiveness
#8
postoperative supplementation with 100 mg of iron polymaltose complex administered orally, twice a day for 8 weeks
increase
iron profile
adult women undergoing post-bariatric anchor-line abdominoplasty
-
evaluate the haematopoietic effectiveness
#9
postoperative supplementation with 100 mg of iron polymaltose complex administered orally, twice a day for 8 weeks
increase
reticulocyte count
adult women undergoing post-bariatric anchor-line abdominoplasty
-
evaluate the haematopoietic effectiveness
#10
postoperative supplementation with 100 mg of iron polymaltose complex administered orally, twice a day for 8 weeks
increase
overall quality of life measured using the Short-Form 36 Health Survey (SF-36) questionnaire
adult women undergoing post-bariatric anchor-line abdominoplasty
-
evaluate the haematopoietic effectiveness
#11
postoperative supplementation with 100 mg of iron polymaltose complex administered orally, twice a day for 8 weeks
decrease
fatigue measured using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
adult women undergoing post-bariatric anchor-line abdominoplasty
-
evaluate the haematopoietic effectiveness
#12
postoperative supplementation with 100 mg of iron polymaltose complex administered orally, twice a day for 8 weeks
neutral
adverse effects
adult women undergoing post-bariatric anchor-line abdominoplasty
-
evaluate the haematopoietic effectiveness
#13
postoperative supplementation with 100 mg of iron polymaltose complex administered orally, twice a day for 8 weeks
neutral
postoperative complications
adult women undergoing post-bariatric anchor-line abdominoplasty
-
evaluate the haematopoietic effectiveness
#14
Abstract

BACKGROUND: Anaemia and iron deficiency are common complications following post-bariatric abdominoplasty. Given the low oral absorbability of iron resulting from bariatric surgery, it has been hypothesised that postoperative intravenously administered iron supplementation could be used to treat anaemia and to prevent the development of iron deficiency in these patients. METHODS/DESIGN: In this multicentre open-label randomised clinical trial, 56 adult women undergoing post-bariatric anchor-line abdominoplasty will be allocated at a ratio of 1:1 for postoperative supplementation with two intravenously administered applications of 200 mg of iron saccharate or postoperative supplementation with 100 mg of iron polymaltose complex administered orally, twice a day for 8 weeks. The primary outcome is the difference in mean haemoglobin levels between the two groups at eight postoperative weeks. Secondary outcomes evaluated at one, four and eight postoperative weeks include iron profile, reticulocyte count, overall quality of life measured using the Short-Form 36 Health Survey (SF-36) questionnaire, fatigue measured using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F), adverse effects and postoperative complications. DISCUSSION: This randomised clinical trial aims to evaluate the haematopoietic effectiveness of intravenously administered iron supplementation in patients undergoing post-bariatric abdominoplasty. A more effective recovery of haemoglobin levels could help improve the patients' quality of life and could provide an improved haematological status in preparation for the subsequent and frequent plastic surgeries these patients undergo. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01857011 (8 May 2013), Universal Trial Number U111-1169-6223, Brazilian Clinical Trials Registry (REBEC): RBR-2JGRKQ .

Medical Subject Headings (MeSH)
AbdominoplastyAdministration, IntravenousAdministration, OralAdolescentAdultAnemiaBariatric SurgeryBiomarkersBrazilClinical ProtocolsDrug Administration ScheduleFemaleFerric CompoundsFerric Oxide, SaccharatedGlucaric AcidHematinicsHematopoiesisHemoglobinsHumansMiddle AgedQuality of LifeResearch DesignSurveys and QuestionnairesTime FactorsTreatment OutcomeYoung Adult
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations1
Citations/Year0.1
Relative Citation Ratio0.05
NIH Percentile2.5%
Research Impact Scores
APT Score0.05
Weight Score1.48
Normalized Score0.67
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