Iron Prehabilitation in Endometrial Cancer

Phase 4

Completed

• Conditions: Endometrial Cancer; Perioperative Complication; Prehabilitation
• Interventions: Drug: Ferrous Gluconate 300 MG

• Registration Number: NCT06049693
• Lead Sponsor: National and Kapodistrian University of Athens

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.

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-04-25
• Study First Submitted QC: 2023-09-17
• Study First Posted: 2023-09-22
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 156

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iron supplementation	Ferrous Gluconate 300 MG	Iron supplementation will be provided in the form of ferrous gluconate 300mg twice a day for a period of 1 month

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Onset of adjuvant treatment per participant	Postoperatively up to 24 weeks	The interval between surgery and adjuvant treatment will be monitored.
Duration of hospitalization per participant	Postoperatively (until patient exit) up to 30 days	The duration of hospitalization per participant 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

Trial Locations

Locations (1)

First department of Obstetrics and Gynecology; 🇬🇷 Athens, Greece