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.
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.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
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 |
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 .