Endometrial Cancer, Perioperative Complication, Prehabilitation
Conditions
Brief summary
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
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.
Interventions
Ferrous Gluconate 300 MG twice a day
Sponsors
National and Kapodistrian University of Athens
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with surgical site infection | Postoperatively (up to 30 days) | Participants will be followed-up to determine the incidence of postoperative surgical site infection |
| Required blood transfusions per participant and aggregated mean differences | Perioperatively (up to 10 days) | The number of perioperative (intraoperative and postoperative) blood transfusions per patient will be monitored and compared among the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with other postoperative infections | Postoperatively (up to 30 days) | Participants will be followed-up to determine the incidence of other postoperative infectious morbidity (other than surgical site infection) |
| Duration of hospitalization per participant | Postoperatively (until patient exit) up to 30 days | The duration of hospitalization per participant will be monitored. |
| Onset of adjuvant treatment per participant | Postoperatively up to 24 weeks | The interval between surgery and adjuvant treatment will be monitored. |
| Survival rates of included participants | Postoperatively (at 3 years postoperatively) | Patients will be screened for recurrence of disease and their survival status will be screened at 3 years |
Countries
Greece
Outcome results
None listed