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Iron Prehabilitation in Endometrial Cancer (IROGYN)

N

National and Kapodistrian University of Athens

Status and phase

Completed
Phase 4

Conditions

Endometrial Cancer
Perioperative Complication
Prehabilitation

Treatments

Drug: Ferrous Gluconate 300 MG

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full description

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.

Enrollment

156 patients

Sex

Female

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

156 participants in 2 patient groups

Iron supplementation
Experimental group
Description:
Iron supplementation will be provided in the form of ferrous gluconate 300mg twice a day for a period of 1 month
Treatment:
Drug: Ferrous Gluconate 300 MG
Control
No Intervention group
Description:
Control patients will be recruited on the ground of no form of iron prehabilitation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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