Prophylactic Oral Iron Supplementation for the Prevention of Iron Deficiency Anemia After Sleeve Gastrectomy: A Prospective Comparative Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Incidence of Iron Deficiency Anemia (IDA) at 6 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Prophylactic Oral Iron Group
Patients from the bariatric surgery unit whose standard postoperative care includes a prophylactic oral iron regimen. This consists of Ferrodep® (30 mg elemental iron per capsule), one capsule every 12 hours (total 60 mg/day), in addition to a daily standard multivitamin.
干预措施: Elemental Iron (Drug)
Prophylactic Oral Iron Group
Patients from the bariatric surgery unit whose standard postoperative care includes a prophylactic oral iron regimen. This consists of Ferrodep® (30 mg elemental iron per capsule), one capsule every 12 hours (total 60 mg/day), in addition to a daily standard multivitamin.
干预措施: Multivitamin with Minerals (Dietary Supplement)
Standard Multivitamin Group
Patients from the bariatric surgery unit whose standard postoperative care includes a daily standard multivitamin only (e.g., Centrum Silver®), which contains approximately 10 mg of iron. No additional prophylactic iron is routinely prescribed.
干预措施: Multivitamin with Minerals (Dietary Supplement)
结局指标
主要结局
Incidence of Iron Deficiency Anemia (IDA) at 6 Months
时间窗: 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).
次要结局
- Change in Hemoglobin Concentration(Baseline, 3 Months, 6 Months)
- Change in Serum Ferritin Level(Baseline, 3 Months, 6 Months)
- Change in Transferrin Saturation (TSAT)(Baseline, 3 Months, 6 Months)
- Incidence of Isolated Iron Deficiency without anemia(3 Months, 6 Months)
- Rate of Oral Iron Intolerance(6 Months Post-Surgery)
- Adherence to Oral Supplementation(3 Months, 6 Months)
- Fatigue Severity Score](Baseline, 3 Months, 6 Months)
- Need for Therapeutic Iron Supplementation(6 Months Post-Surgery)
研究者
Ahmed Eid Ali Ahmed Aziz
Lecturer
Cairo University