Perioperative Management of Preoperative Anemia in Colorectal Cancer

Active, not recruiting

• Conditions: Colorectal Cancer; Anemia

• Registration Number: NCT06026618
• Lead Sponsor: Consorci Sanitari Integral

Brief Summary

Both preoperative anemia (PA) and perioperative blood transfusion can contribute on poorer outcomes after colon cancer surgery. Anemia is known to be associated with a slower recovery after surgery thus often worsening short-term results, and allogenic red blood cells transfusion (ARBT) are known to promote systemic inflammatory response and affect overall and cancer-specific survival.

Patient Blood Management (PBM) systems are an evidence-based multimodal approach focused on safe and rational use of blood products, mainly through a proper PA assessment, a minimization of procedural blood loos and strict transfusion policies. Given the high prevalence of PA in patients with colorectal cancer (CRC), and its association with adverse events, it is expected that PBM implementation in said scenario carries a decrease in complications and an improved survival rate. Available literature to date supports preoperative anaemia screening and restrictive transfusion policies, nevertheless barriers exist that limit the expected implementation of PBM systems in colorectal surgery.

The present study aims to evaluate feasibility of a PBM pathway implementation in a high-volume CRC Surgery Unit based on completion of anemia screening and treatment before surgery and changes of allogenic products use along the years. The objective is to estimate the impact of a proper preoperative optimization with iron intravenous infusion (IVI) on PA measured from changes Hemoglobin (Hb) levels in comparison to those of non-anemic patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2019-01-31
• Study First Submitted: 2023-07-11
• Status Verified: 2023-08
• Study First Submitted QC: 2023-09-04
• Last Update Submitted: 2023-09-04
• Study First Posted: 2023-09-07
• Last Update Posted: 2023-09-07
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1294

Inclusion Criteria

• Patients diagnosed with Colorectal Cancer
• Patients with an indication of elective radical surgery

Exclusion Criteria

• treatment with red blood cells transfusion before assessment in the PBM Anemia Clinic
• non-iron deficient anemia
• treatment with Sucrose-based IVI or Oral Iron (OI) preparations not strictly controlled by the PBM clinic

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin	Baseline and up to 30 days	Change in serum hemoglobin concentration between baseline (at the moment of initial colorectal clinic visit) and day of surgery

Secondary Outcome Measures

Name	Time	Method
Total iron dose	up to 30 days	Total iron dose administered from the first visit until surgery
number of days needed to complete treatment	up to 30 days	days of treatment before surgery
number of complications related to IVI administration	up to 30 days	number of complications related to IVI administration

Trial Locations

Locations (1)

Hospital de Sant Joan Despí, CSI; 🇪🇸 Sant Joan Despí, Barcelona, Spain