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NCT Number: NCT06049693

Iron Prehabilitation in Endometrial Cancer

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.

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Perioperative Complication Prehabilitation Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–79 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

First department of Obstetrics and Gynecology

Athens, 11523, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferrous Gluconate 300 MG

Drug

Ferrous Gluconate 300 MG twice a day

Primary outcomes

  1. Number of participants with surgical site infection

    Time frame: Postoperatively (up to 30 days)

    Participants will be followed-up to determine the incidence of postoperative surgical site infection

  2. Required blood transfusions per participant and aggregated mean differences

    Time frame: 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 outcomes

  1. Number of participants with other postoperative infections

    Time frame: Postoperatively (up to 30 days)

    Participants will be followed-up to determine the incidence of other postoperative infectious morbidity (other than surgical site infection)

  2. Duration of hospitalization per participant

    Time frame: Postoperatively (until patient exit) up to 30 days

    The duration of hospitalization per participant will be monitored.

  3. Onset of adjuvant treatment per participant

    Time frame: Postoperatively up to 24 weeks

    The interval between surgery and adjuvant treatment will be monitored.

  4. Survival rates of included participants

    Time frame: Postoperatively (at 3 years postoperatively)

    Patients will be screened for recurrence of disease and their survival status will be screened at 3 years

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study title

Iron Prehabilitation and Perioperative Infectious Diseases of Endometrial Cancer Patients

Acronym: IROGYN

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 22, 2023
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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