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Preoperative i.v. Iron Substitution in Patients With Colon Cancer

Preoperative i.v. Iron Substitution in Patients With Colon Carcinoma and Iron-deficiency Anemia

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04653181
Acronym
PREFECO
Enrollment
514
Registered
2020-12-04
Start date
2020-10-01
Completion date
2025-12-31
Last updated
2024-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

Keywords

postoperative complications

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

Interventions

DRUGFerric carboxymaltose

Iron-arm treated with Ferric carboxymaltose, non-iron arm without

Sponsors

Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
postoperative complications30 daysAt 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

Secondary

MeasureTime frameDescription
Need for red blood cell transfusion30 daysNumber of Participants in need for red blood cells transfusion per arm

Countries

Finland

Contacts

Primary ContactSuvi K Rasilainen, Md, PhD
suvi.rasilainen@hus.fi+35894711

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026