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

Not Applicable

Recruiting

• Conditions: Colon Cancer
• Interventions: Drug: Ferric carboxymaltose

• Registration Number: NCT04653181
• Lead Sponsor: Helsinki University Central Hospital

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

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-11-26
• Study First Posted: 2020-12-04
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 514

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)

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Exclusion Criteria

• hyperreactivity for Ferinject
• haemochromatosis
• refusal for participation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iron arm	Ferric carboxymaltose	Half of patients get i.v. iron preoperatively

Primary Outcome Measures

Name	Time	Method
postoperative complications	30 days	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

Secondary Outcome Measures

Name	Time	Method
Need for red blood cell transfusion	30 days	Number of Participants in need for red blood cells transfusion per arm

Trial Locations

Locations (1)

Jorvi Hospital; 🇫🇮 Espoo, HUS, Finland