IROGYN: Iron Prehabilitation in Endometrial Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| 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 |
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First department of Obstetrics and Gynecology | Athens | Greece | 11523 |
Sponsors and Collaborators
- National and Kapodistrian University of Athens
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
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