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Effect of an Enhanced PerOperative Care and Health Program

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25119
Enrollment
3000
Registered
2016-03-03
Start date
2016-03-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Surgical site infections (SSI's), randomised study, randomized controlled trial,

Interventions

The EPOCH bundle An evidence-based, enhanced perioperative care program that can be applied without introduction of new material in the OR, added on top of usual care, comprising of: 1. Normothermia,

Sponsors

Academic Medical Center (AMC), Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Adult patients ¡Ý 18 years - Elective open abdominal surgery and laparoscopic colorectal surgery

Exclusion criteria

Exclusion criteria: - Emergency surgery - Reoperation for complications from recent surgery (within 3 months) - The inability of reading/understanding and filling in the questionnaires - Participation in another study with interference of study outcomes - Pregnancy

Design outcomes

Primary

MeasureTime frame
Incidence rate of SSI evaluated from the Dutch National Surgical Complication Registry (LHCR). Parallel assessment of incidence rate of SSI by the CDC definition through medical chart reviews.

Secondary

MeasureTime frame
- SSI rate evaluated at 30 days and 3 months follow-up by the CDC definition through medical chart review. - Readmission rate at 30 days follow up through LHCR registration - WHO disability assessment schedule 2.0 by self-administration through online/paper-form questionnaires at postop day 30, 60 and 90. - (In)direct medical and non-medical costs, quality adjusted life years (QALY) (Methods described under CEA and BIA. See below) - Anastomotic leakage rate at 30 days follow up through LHCR registration and medical chart review. - Incisional hernia rate by medical chart review (diagnosed by either physical examination and/or ultrasonography or CT) one year after surgery.

Contacts

Public ContactNiels Wolfhagen

Academisch Medisch Centrum - Afdeling chirurgie G4-134

epoch@amc.nlTelephone : 020-5665477

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)