To evaluate the effect of an enhanced perioperative care program added on to usual care. It is hypothesized that the enhanced perioperative care and health protection (EPOCH) program added on to usual care reduces postoperative surgical site…
ID
Bron
Verkorte titel
Aandoening
Surgical site infections (SSI's), randomised study, randomized controlled trial,
Ondersteuning
Innovatie fonds zorgverzekeraars
Johnson & Johnson Ethicon
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
In this randomized controlled multicenter trial we evaluate, in adults undergoing elective abdominal surgery, whether an enhanced perioperative care and health protection program, reduces postoperative surgical site infections compared to usual care alone.
Doel van het onderzoek
To evaluate the effect of an enhanced perioperative care program added on to usual care. It is hypothesized that the enhanced perioperative care and health protection (EPOCH) program added on to usual care reduces postoperative surgical site infections compared to usual care alone
Onderzoeksopzet
Follow-up at discharge, 1,2, & 3 months after surgery.
Onderzoeksproduct en/of interventie
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, 2. Supplemental oxygen, 3. Normovolemia, 4. Normoglycemia and 5. Surgical site handling.
The control group will receive usual care standard oxygenation (30% FiO2), standard hemodynamic therapy based on fluid balance and third space losses, no active preoperative and postoperative warming, no active control of hyperglycemia, and conventional surgical site handling. In the Netherlands the POWI (PostOperative Wound Infection) bundle is usual care and consists of hygiene discipline (focusing on door movements), timing of antibiotic prophylaxis, normothermia, and no preoperative hair removal.
Publiek
Niels Wolfhagen
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
Telephone : 020-5665477
epoch@amc.nl
Wetenschappelijk
Niels Wolfhagen
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
Telephone : 020-5665477
epoch@amc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Adult patients ¡Ý 18 years
- Elective open abdominal surgery and laparoscopic colorectal surgery
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5572 |
| NTR-old | NTR5694 |
| Ander register | METC AMC : METC 2015_121 EPOCH trial |