Clinical trial NCT04653181: Preoperative i.v. Iron Substitution in Patients With Colon Cancer
Official title: Preoperative i.v. Iron Substitution in Patients With Colon Carcinoma and Iron-deficiency Anemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colon Cancer
Keywords: postoperative complications
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 514
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: About 70% of colon cancer patients are anemic. Preoperative anemia in patients with colorectal cancer is associated with both impaired disease-free survival and overall survival. The purpose of this study is to compare the effects of preoperative iv iron substitution on postoperative recovery in preoperatively anemic (male Hb \<130, female Hb \<120) and iron deficient colon cancer patients in a prospective setup. As a primary outcome, the effect of iv-iron substitution on postoperative complications is investigated.

Detailed description: Randomized preoperative iron substitution for patient with iron deficient anemia

Eligibility criteria: Inclusion Criteria:

* Age\> 18 years
* 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:

* hyperreactivity for Ferinject
* haemochromatosis
* refusal for participation

Primary outcomes:
measure: postoperative complications
timeFrame: 30 days
Secondary outcomes:
measure: Need for red blood cell transfusion
timeFrame: 30 days
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Jorvi Hospital
state: HUS
Study officials:
affiliation: Abdominal centre, HUCH
name: Selja K Koskensalo, Md, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.