Preoperative i.v. Iron Substitution in Patients With Colon Cancer
NCT ID: NCT04653181
Last Updated: 2024-02-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
514 participants
INTERVENTIONAL
2020-10-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Iron arm
Half of patients get i.v. iron preoperatively
Ferric carboxymaltose
Iron-arm treated with Ferric carboxymaltose, non-iron arm without
non-iron arm
Half of patients are treated without i.v. iron substitution
No interventions assigned to this group
Interventions
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Ferric carboxymaltose
Iron-arm treated with Ferric carboxymaltose, non-iron arm without
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Dg: Colon ca
* The planned measure: the colon resection
* Men: Hb \<130, women: Hb \<120 and iron deficiency (elevated TfR, low TrFesat or low ferritin)
Exclusion Criteria
* haemochromatosis
* refusal for participation
18 Years
100 Years
ALL
No
Sponsors
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Helsinki University Central Hospital
OTHER
Responsible Party
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Selja Koskensalo
Consultant, abdominal surgeon,Md, PhD
Principal Investigators
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Selja K Koskensalo, Md, PhD
Role: STUDY_DIRECTOR
Abdominal centre, HUCH
Locations
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Jorvi Hospital
Espoo, HUS, Finland
Countries
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Central Contacts
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Facility Contacts
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Suvi K Rasilainen, Md, PhD
Role: primary
References
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Zhen L, Zhe S, Zhenning W, Zhifeng M, Zhidong L, Xiaoxia L, Jianguang Y, Huimian X. Iron-deficiency anemia: a predictor of diminished disease-free survival of T3N0M0 stage colon cancer. J Surg Oncol. 2012 Mar 15;105(4):371-5. doi: 10.1002/jso.22032. Epub 2011 Jul 14.
Calvet X, Gene E, AngelRuiz M, Figuerola A, Villoria A, Cucala M, Mearin F, Delgado S, Calleja JL. Cost-minimization analysis favours intravenous ferric carboxymaltose over ferric sucrose or oral iron as preoperative treatment in patients with colon cancer and iron deficiency anaemia. Technol Health Care. 2016;24(1):111-20. doi: 10.3233/THC-151074.
Calleja JL, Delgado S, del Val A, Hervas A, Larraona JL, Teran A, Cucala M, Mearin F; Colon Cancer Study Group. Ferric carboxymaltose reduces transfusions and hospital stay in patients with colon cancer and anemia. Int J Colorectal Dis. 2016 Mar;31(3):543-51. doi: 10.1007/s00384-015-2461-x. Epub 2015 Dec 22.
Ristescu I, Pintilie G, Filip D, Jitca M, Fecheta R, Florescu I, Scripcariu V, Filipescu D, Grigoras I. Perioperative Anemia and Transfusion in Colorectal Cancer Patients. Chirurgia (Bucur). 2019 Mar-Apr;114(2):234-242. doi: 10.21614/chirurgia.114.2.234.
Dunne JR, Gannon CJ, Osborn TM, Taylor MD, Malone DL, Napolitano LM. Preoperative anemia in colon cancer: assessment of risk factors. Am Surg. 2002 Jun;68(6):582-7.
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
Other Identifiers
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SKoskensalo
Identifier Type: -
Identifier Source: org_study_id
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