Iron Prehabilitation in Endometrial Cancer (IROGYN)

March 28, 2024 updated by: Nikolaos Thomakos, National and Kapodistrian University of Athens

Iron Prehabilitation and Perioperative Infectious Diseases of Endometrial Cancer Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11523
        • First department of Obstetrics and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iron supplementation
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
Ferrous Gluconate 300 MG twice a day
No Intervention: Control
Control patients will be recruited on the ground of no form of iron prehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Postoperatively (up to 30 days)
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.
Perioperatively (up to 10 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Postoperatively (up to 30 days)
Duration of hospitalization per participant
Time Frame: Postoperatively (until patient exit) up to 30 days
The duration of hospitalization per participant will be monitored.
Postoperatively (until patient exit) up to 30 days
Onset of adjuvant treatment per participant
Time Frame: Postoperatively up to 24 weeks
The interval between surgery and adjuvant treatment will be monitored.
Postoperatively up to 24 weeks
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
Postoperatively (at 3 years postoperatively)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

April 25, 2023

First Submitted That Met QC Criteria

September 17, 2023

First Posted (Actual)

September 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 129/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD will be shared upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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