Iron Prehabilitation in Endometrial Cancer

Study Overview
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Brief Summary
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Endometrial cancer patients often have iron deficiency anemia before surgery, which can be effectively treated with oral iron supplementation. Anemia and blood transfusions have been previously associated with perioperative infectious diseases. In the present study the investigators will evaluate the impact of perioperative iron supplementation on the incidence of perioperative infections.

Detailed Description
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Prehabilitation has a multimodal conception based on three fundamental pillars: improvement of the patient's physical condition, nutritional optimization and other measures such as smoking cessation and correction of anemia. As in the case of multimodal rehabilitation protocols, the actions of prehabilitation programs have synergistic effects, that is, small changes that, by themselves, do not have clinical significance but when added up, they produce a significant improvement in the postoperative evolution of patients. Surgical site infections (SSIs) are considered to be the most common nosocomial infections among surgical patients and constitute a heavy and potentially preventable economic burden on health care providers. Although the impact of blood transfusion on the risk of SSI remains controversial, several studies have shown that anemia and transfusion predispose to postoperative bacterial infections. In the present study the investigators seek to evaluate the impact of per os iron prehabilitation on perioperative outcomes of endometrial cancer patients, including need for transfusion and infectious morbidity.

Official Title
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Iron Prehabilitation and Perioperative Infectious Diseases of Endometrial Cancer Patients

Conditions
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Endometrial Cancer, Perioperative Complication, Prehabilitation

Intervention / Treatment
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* Drug: Ferrous Gluconate 300 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with endometrial cancer enrolled in the surgical list Exclusion Criteria: Women with endometrial cancer requiring immediate surgery due to life-threatening hemorrhage

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iron supplementation<br>Iron supplementation will be provided in the form of ferrous gluconate 300mg twice a day for a period of 1 month | Drug: Ferrous Gluconate 300 MG<br>* Ferrous Gluconate 300 MG twice a day<br>|
| No Intervention: Control<br>Control patients will be recruited on the ground of no form of iron prehabilitation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with surgical site infection | Participants will be followed-up to determine the incidence of postoperative surgical site infection | Postoperatively (up to 30 days) | 
| Required blood transfusions per participant and aggregated mean differences | The number of perioperative (intraoperative and postoperative) blood transfusions per patient will be monitored and compared among the two groups. | Perioperatively (up to 10 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with other postoperative infections | Participants will be followed-up to determine the incidence of other postoperative infectious morbidity (other than surgical site infection) | Postoperatively (up to 30 days) | 
| Duration of hospitalization per participant | The duration of hospitalization per participant will be monitored. | Postoperatively (until patient exit) up to 30 days | 
| Onset of adjuvant treatment per participant | The interval between surgery and adjuvant treatment will be monitored. | Postoperatively up to 24 weeks | 
| Survival rates of included participants | Patients will be screened for recurrence of disease and their survival status will be screened at 3 years | Postoperatively (at 3 years postoperatively) |