Study Results
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Basic Information
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COMPLETED
PHASE4
156 participants
INTERVENTIONAL
2023-01-01
2024-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Iron supplementation
Iron supplementation will be provided in the form of ferrous gluconate 300mg twice a day for a period of 1 month
Ferrous Gluconate 300 MG
Ferrous Gluconate 300 MG twice a day
Control
Control patients will be recruited on the ground of no form of iron prehabilitation
No interventions assigned to this group
Interventions
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Ferrous Gluconate 300 MG
Ferrous Gluconate 300 MG twice a day
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
79 Years
FEMALE
No
Sponsors
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National and Kapodistrian University of Athens
OTHER
Responsible Party
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Nikolaos Thomakos
Associate Professor of Obstetrics and Gynecology
Locations
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First department of Obstetrics and Gynecology
Athens, , Greece
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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129/20
Identifier Type: -
Identifier Source: org_study_id
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