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The Effect of an Enhanced PerOperative Care and Health Protection Programme on Surgical Site Infections (SSI) after elective abdominal surgery

The Effect of an Enhanced PerOperative Care and Health Protection Programme on Surgical Site Infections (SSI) after elective abdominal surgery - EPOCH trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50566
Enrollment
1433
Registered
2015-07-22
Start date
2016-03-01
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Surgical site infection Surgical wound infection

Interventions

An evidence-based, enhanced perioperative care program that can be applied without introduction of new material in the OR, added to usual care, comprising: 1. Normothermia - Active perioperative warm

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult patients undergoing elective abdominal surgery resulting in an incision larger than 5 cm

Exclusion criteria

Exclusion criteria: Emergency surgery, reoperations because of complicated surgery within 90 days and two staged surgical procedures

Design outcomes

Primary

MeasureTime frame
Incidence rate of SSI at 30 days follow-up, evaluated from the Dutch National Surgical Complication Registry (LHCR), a complication registry that has been implemented for over fifteen years now in Dutch Hospitals.

Secondary

MeasureTime frame
Secondary endpoints: SSI rate evaluated at 3 months follow-up, WHO disability assessment schedule 2.0, (in)direct medical and non-medical costs, quality adjusted life years (QALY) , anastomotic leakage rate, incisional hernia rate, Serious adverse events (SAE) and mortality. Parallel assessment of incidence rate of SSI, by the CDC definition, by medical chart reviews to correct possible registration effect. Additional secondary outcomes for participants in the AMC: Local tissue oxygenation from admission to the surgical unit until discharge from recovery back to the ward, immunologic effects defined by neutrophil intracellular ROS generation, phagocytosis assays, plasma cytokine concentrations, HLA-DRA mRNA expression, malondialdehyde concentration, blood gas parameters, and ex vivo whole blood stimulation.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 3, 2026