Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS
Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
Iron deficiency has been reported in up to 35% of patients with a gynecologic malignancy.
These patients often require surgical intervention to determine the stage and to treat their
illness. Blood transfusions occur in approximately 14% of these surgeries and carry immediate
and long-term risks, including surgical site infection, cancer recurrence, and increased
surgical length of stay. Intravenous iron formulations have the potential to rapidly correct
anemia in patients with gynecologic malignancy and potentially decrease blood transfusion and
complications following surgery. This prospective, randomized, placebo-controlled, double
blind study aims to assess the effectiveness of preoperative ferric derisomaltose/iron
isomaltoside compared to placebo in correcting preoperative hemoglobin in patients undergoing
surgery for gynecologic malignancy. The primary outcome is to assess the effectiveness of
this formulation on pre-operative hemoglobin, and the feasibility of a larger, outcomes
based, study in the future. Exploratory outcomes are to assess the effect of preoperative
intravenous iron on surgical length of stay, complications, and patient-reported quality of
life.