Iron Prehabilitation in Endometrial Cancer

Endometrial Cancer Clinical Trial

— IROGYN  

Official title:

Iron Prehabilitation and Perioperative Infectious Diseases of Endometrial Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06049693
• Other study ID #: 129/20
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: March 2024
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Perioperative Complication
• Prehabilitation

Intervention

Drug:
• Ferrous Gluconate 300 MG
Ferrous Gluconate 300 MG twice a day

Locations

Country	Name	City	State
Greece	First department of Obstetrics and Gynecology	Athens

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

References & Publications (4)

Amstad G, Geiger J, Werlen L, Montavon C, Heinzelmann V. Perioperative management with ferric carboxymaltose and tranexamic acid to reduce transfusion rate in gynaecological carcinoma surgery (TRANAFER-Study): study protocol for a single-blind, monocentre, randomised trial. BMJ Open. 2022 Sep 26;12(9):e057381. doi: 10.1136/bmjopen-2021-057381. — View Citation

Bath M, Viveiros A, Schaefer B, Klein S, Pammer LM, Wagner S, Lorenz A, Rugg C, Gasser E, Ninkovic M, Panzer M, Pertler E, Fries D, Tilg H, Weiss G, Petzer V, Ofner-Velano D, Zoller H. Impact of preoperative anemia, iron-deficiency and inflammation on survival after colorectal surgery-A retrospective cohort study. PLoS One. 2022 Jul 27;17(7):e0269309. doi: 10.1371/journal.pone.0269309. eCollection 2022. — View Citation

Fung PLP, Lau VNM, Ng FF, Leung WW, Mak TWC, Lee A. Perioperative changes in haemoglobin and ferritin concentrations from preoperative intravenous iron isomaltoside for iron deficiency anaemia in patients with colorectal cancer: A pilot randomised controlled trial. PLoS One. 2022 Jun 30;17(6):e0270640. doi: 10.1371/journal.pone.0270640. eCollection 2022. — View Citation

Tyan P, Taher A, Carey E, Amdur R, Messersmith C, Robinson HN, Gu A, Vargas MV, Moawad GN. Effect of Perioperative Transfusion on Postoperative Morbidity Following Minimally Invasive Hysterectomy for Benign Indications. J Minim Invasive Gynecol. 2020 Jan;27(1):200-205. doi: 10.1016/j.jmig.2019.03.021. Epub 2019 Mar 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with surgical site infection	Participants will be followed-up to determine the incidence of postoperative surgical site infection	Postoperatively (up to 30 days)
Primary	Required blood transfusions per participant and aggregated mean differences	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	Number of participants with other postoperative infections	Participants will be followed-up to determine the incidence of other postoperative infectious morbidity (other than surgical site infection)	Postoperatively (up to 30 days)
Secondary	Duration of hospitalization per participant	The duration of hospitalization per participant will be monitored.	Postoperatively (until patient exit) up to 30 days
Secondary	Onset of adjuvant treatment per participant	The interval between surgery and adjuvant treatment will be monitored.	Postoperatively up to 24 weeks
Secondary	Survival rates of included participants	Patients will be screened for recurrence of disease and their survival status will be screened at 3 years	Postoperatively (at 3 years postoperatively)