Perioperative Management of Preoperative Anemia in Colorectal Cancer

NCT ID: NCT06026618

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1294 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-01
• Study Completion Date: 2024-01-31

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.

Conditions

Anemia; Colorectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

cohort 1

non-anemic patients (Hb \> 13 g/dL)

No interventions assigned to this group

cohort 2

mildly anemic patients (Hb 12-13 mg/dL) without criteria for IVI therapy

No interventions assigned to this group

cohort 3

patients treated with IVI (Hb \< 12mg/dL or Hb 12-13mg/dL with iron deficiency or risk factors for bleeding)

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consorci Sanitari Integral

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital de Sant Joan Despí, CSI

Sant Joan Despí, Barcelona, Spain

Countries

Spain

Other Identifiers

21/19

Identifier Type: -

Identifier Source: org_study_id