Iron Deficiency Anemia, Obesity, Sleeve Gastrectomy
Conditions
Keywords
Laparoscopic Sleeve Gastrectomy, Bariatric Surgery, Iron Deficiency Anemia, Iron Supplementation, Multivitamin, Morbid Obesity, Observational Study
Brief summary
The goal of this observational study is to learn if taking extra iron pills after weight loss surgery helps prevent low iron and anemia compared to just taking a standard multivitamin. The main question it aims to answer is: Does a specific iron supplementation plan lower the number of patients who develop iron deficiency anemia in the 6 months after sleeve gastrectomy surgery? Researchers will compare two groups of patients from different hospital units to see if the extra iron works: Patients from one unit who take a prophylactic iron supplement (Ferrodep, 60 mg per day) in addition to their standard multivitamin. Patients from another unit who take only a standard multivitamin (Centrum Silver). Participants in this study will: * Have their blood tested for iron and anemia levels before surgery, and again at 3 and 6 months after surgery, as part of their regular post-operative care. * Be asked about their health and quality of life during follow-up clinic visits. * Have their medical information from their hospital records reviewed by the study team to track their progress.
Detailed description
Background and Rationale Iron deficiency anemia (IDA) is a prevalent and clinically significant long-term complication following Laparoscopic Sleeve Gastrectomy (LSG), the most commonly performed bariatric procedure worldwide. Despite universal multivitamin supplementation, the incidence of IDA rises steadily post-operatively, impacting patient quality of life, cognitive function, and healthcare utilization. A critical evidence gap exists regarding the efficacy of routine prophylactic oral iron supplementation compared to a strategy of standard multivitamin use with iron monitoring. Current guidelines lack consensus due to insufficient comparative long-term data. This study aims to provide high-level evidence to inform postoperative protocols by directly comparing these two distinct management strategies. Study Design and Setting This is a prospective, observational, comparative cohort study conducted within the bariatric surgery units of Kasr Al-Ainy Hospital, Cairo University. The study leverages existing, routine clinical practices at two participating units, allowing for a real-world comparison of outcomes. Participants will be managed according to the standard post-operative supplementation protocol of their treating surgical unit; the research protocol does not assign interventions. Study Cohorts Eligible participants will be enrolled into one of two cohorts based on the standard care protocol of their surgical unit: Prophylactic Iron Cohort: Patients whose standard care includes a daily prophylactic dose of 60 mg elemental iron (administered as Ferrodep®, 30 mg capsule every 12 hours) in addition to a daily standard multivitamin. Standard Multivitamin Cohort: Patients whose standard care includes a daily standard multivitamin only (e.g., Centrum Silver®), which contains approximately 10 mg of iron, with no additional prophylactic iron. Study Procedures and Assessments Consecutively enrolled patients scheduled for primary LSG will be assessed pre-operatively (baseline) and at 3 and 6 months post-operatively. Data collection will include standardized laboratory panels (hemoglobin, ferritin, iron studies, complete blood count indices), documentation of supplementation adherence, and patient-reported outcome measures. All primary and secondary outcome measures are pre-specified and listed in the designated module. Statistical Considerations The primary outcome is the cumulative incidence of IDA at 6 months post-surgery, with IDA defined per protocol-specific laboratory criteria. Secondary outcomes include longitudinal changes in hematological parameters, adherence rates, and patient-reported fatigue. A sample size of 66 participants (33 per cohort) was calculated to provide 85% power to detect a significant difference in the primary outcome. Data will be analyzed using SPSS software with appropriate statistical tests for between-group comparisons, as detailed in the statistical analysis plan.
Interventions
DRUGElemental Iron
Prophylactic oral iron supplement (Ferrodep®), prescribed as part of the standard post-operative care protocol at the participating unit. Each capsule contains 30 mg of elemental iron. The regimen is one capsule every 12 hours, for a total daily dose of 60 mg elemental iron, taken in addition to a daily multivitamin.
DIETARY_SUPPLEMENTMultivitamin with Minerals
A standard daily multivitamin with minerals (Centrum Silver®), prescribed as part of the routine post-operative care. This formulation contains approximately 10 mg of elemental iron. For participants in this unit's protocol, no additional prophylactic iron is routinely prescribed.
Sponsors
Cairo University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 to 65 years scheduled to undergo primary laparoscopic sleeve gastrectomy (LSG). * Capable of understanding and providing written informed consent for participation. * Able and willing to commit to the 6-month post-operative follow-up schedule at the bariatric clinic.
Exclusion criteria
* Prior history of major gastrointestinal surgery (e.g., bowel resection, gastrectomy) that could independently affect iron absorption. * Pre-existing malabsorptive conditions (e.g., inflammatory bowel disease, celiac disease). * Diagnosis of other known forms of anemia (e.g., thalassemia, vitamin B12/folate deficiency, anemia of chronic disease) that would confound the diagnosis of iron deficiency anemia (IDA). * Any condition that, in the investigator's judgment, would interfere with full participation in the study or pose a significant risk.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Iron Deficiency Anemia (IDA) at 6 Months | 6 Months Post-Surgery | Proportion of participants diagnosed with IDA. Diagnosis requires: 1) Anemia (Hemoglobin \<13 g/dL in males or \<12 g/dL in females), AND 2) Iron Deficiency, defined by at least one of: serum ferritin \<30 ng/mL, TIBC \>450 µg/dL, or serum iron \<75 µg/dL (male)/\<60 µg/dL (female). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin Concentration | Baseline, 3 Months, 6 Months | Mean change in hemoglobin concentration (g/dL) from baseline to follow-up. |
| Change in Serum Ferritin Level | Baseline, 3 Months, 6 Months | Mean change in serum ferritin concentration (ng/mL) from baseline to follow-up. |
| Change in Transferrin Saturation (TSAT) | Baseline, 3 Months, 6 Months | Mean change in Transferrin Saturation percentage, calculated from serum iron and TIBC. |
| Incidence of Isolated Iron Deficiency without anemia | 3 Months, 6 Months | Proportion of participants with serum ferritin \<30 ng/mL and normal hemoglobin (≥12 g/dL female, ≥13 g/dL male). |
| Rate of Oral Iron Intolerance | 6 Months Post-Surgery | Proportion experiencing gastrointestinal effects leading to dose reduction, interruption, or discontinuation of iron. |
| Adherence to Oral Supplementation | 3 Months, 6 Months | Adherence expressed as the percentage of prescribed doses taken, calculated from pill count at follow-up clinic visits. |
| Fatigue Severity Score] | Baseline, 3 Months, 6 Months | Mean score on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale.The FACIT-Fatigue scale consists of 13 items, with total scores ranging from 0 to 52, where higher scores indicate less fatigue and better quality of life. |
| Need for Therapeutic Iron Supplementation | 6 Months Post-Surgery | Proportion of participants who require initiation of new therapeutic iron during follow-up per clinician judgment. |
Countries
Egypt
Contacts
CONTACTAhmed Eid Aziz, Lecturer
PRINCIPAL_INVESTIGATORAziz
Cairo University
Outcome results
None listed