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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.
Randomized preoperative iron substitution for patient with iron deficient anemia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron arm | Experimental | Half of patients get i.v. iron preoperatively |
|
| non-iron arm | No Intervention | Half of patients are treated without i.v. iron substitution |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric carboxymaltose | Drug | Iron-arm treated with Ferric carboxymaltose, non-iron arm without |
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative complications | At study, difference between arms will be evaluated: Complications are analysed using Clavien-Dindo classification https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1360123/bin/3TT1.jpg | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Need for red blood cell transfusion | Number of Participants in need for red blood cells transfusion per arm | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suvi K Rasilainen, Md, PhD | Contact | +35894711 | +358504271748 | suvi.rasilainen@hus.fi |
| Name | Affiliation | Role |
|---|---|---|
| Selja K Koskensalo, Md, PhD | Abdominal centre, HUCH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jorvi Hospital | Recruiting | Espoo | HUS | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21761412 | Background | 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. | |
| 26409561 | Background | 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. |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
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| 26694926 | Background | 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. |
| 31060656 | Background | 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. |
| 12079143 | Background | 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. |
| 15273542 | Background | 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. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |