Endometrial Cancer Clinical Trial
— IROGYNOfficial title:
Iron Prehabilitation and Perioperative Infectious Diseases of Endometrial Cancer Patients
Verified date | March 2024 |
Source | National and Kapodistrian University of Athens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Greece | First department of Obstetrics and Gynecology | Athens |
Lead Sponsor | Collaborator |
---|---|
National and Kapodistrian University of Athens |
Greece,
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
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) |
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