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This study aimed to explore the effects of preoperative intravenous isomaltose iron supplementation versus placebo on postoperative Hb improvement, prevention of postoperative anemia, and improvement in quality of life in patients undergoing bariatric surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | 3±1 days before the operation, intravenous infusion of isomaltose iron injection was administered. The dosage was in accordance with the drug instructions. The maximum single infusion dose was 20mg/kg. If the dose could not be made up in one infusion, the remaining dose should be made up every other week. |
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| Placebo group | Placebo Comparator | At the same time point, the same dose of physiological saline was infused. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron Isomaltoside injection | Drug | Patients in the isomaltan iron group received intravenous isomaltan iron dissolved in 250 ml of normal saline 3 days prior to surgery. The patients' iron requirements were calculated using a simplified scale, with a maximum single dose of 20 mg/kg. If the dose was insufficient in a single administration, a second infusion was required every other week. The placebo group received an equal volume of 0.9% normal saline. Simplified scale: Hemoglobin (g/L) patient weight <50kg 50-70kg >70kg ≥100 500mg 1000mg 1500mg <100 500mg 1500mg 2000mg |
| Measure | Description | Time Frame |
|---|---|---|
| changes in Hb concentration compared to baseline | 3 months post-surgery, |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of anemia | 3 months, 6 months and 12 months after surgery | |
| Iron metabolism indicators (serum ferritin, serum iron, total iron binding capacity, transferrin saturation) | 3 months, 6 months, and 12 months post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nianrong Zhang Zhang | Contact | +86 188 1048 8650 | znrsd@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | China |
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| Physiological saline solution (as placebo) | Drug | At the same time point, the same dose of physiological saline was infused as the experimental group. |
|
| The proportion of patients requiring re-treatment for iron deficiency anemia within 12 months post-surgery (Hb < 11 g/dL, SF < 30 μg/L, or SF < 100 μg/L and TSAT < 20%). | 12 months post-surgery |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D000740 | Anemia |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C557707 | iron isomaltoside 1000 |
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