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Effect of an Enhanced PerOperative Care and Health Program


- candidate number24070
- NTR NumberNTR5694
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-mrt-2016
- Secondary IDsMETC 2015_121 EPOCH trial 
- Public TitleEffect of an Enhanced PerOperative Care and Health Program
- Scientific TitleEffect of an Enhanced PerOperative Care and Health Protection Program on Surgical Site Infections (SSI) after elective abdominal surgery
- ACRONYMEPOCH
- hypothesisTo 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
- Healt Condition(s) or Problem(s) studiedInfection prevention
- Inclusion criteria- Adult patients 18 years
- Elective open abdominal surgery and laparoscopic colorectal surgery
- 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2016
- planned closingdate1-dec-2018
- Target number of participants3000
- InterventionsThe 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.
- Primary outcomeIncidence 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 outcome- 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.
- TimepointsFollow-up at discharge, 1,2, & 3 months after surgery.
- Trial web sitewww.epochtrial.com
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Quirine J.J. Boldingh
- CONTACT for SCIENTIFIC QUERIES Quirine J.J. Boldingh
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Innovatiefonds zorgverzekeraars, Johnson & Johnson
- Publications
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD3-mrt-2016 - 15-apr-2016


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