No registrations found.
ID
Source
Brief title
Health condition
Surgical site infections (SSI's), randomised study, randomized controlled trial,
Sponsors and support
Innovatie fonds zorgverzekeraars
Johnson & Johnson Ethicon
Intervention
Outcome measures
Primary outcome
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 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.
Background summary
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.
Study objective
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
Study design
Follow-up at discharge, 1,2, & 3 months after surgery.
Intervention
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.
Niels Wolfhagen
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
Telephone : 020-5665477
epoch@amc.nl
Niels Wolfhagen
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
Telephone : 020-5665477
epoch@amc.nl
Inclusion criteria
- Adult patients ¡Ý 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5572 |
| NTR-old | NTR5694 |
| Other | METC AMC : METC 2015_121 EPOCH trial |