Effect of an Enhanced PerOperative Care and Health Program
Completed
- Conditions
- Surgical site infections (SSI's), randomised study, randomized controlled trial,
- Registration Number
- NL-OMON25119
- Lead Sponsor
- Academic Medical Center (AMC), Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3000
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method - SSI rate evaluated at 30 days and 3 months follow-up by the CDC definition through medical chart review.<br /><br>- Readmission rate at 30 days follow up through LHCR registration<br /><br>- WHO disability assessment schedule 2.0 by self-administration through online/paper-form questionnaires at postop day 30, 60 and 90.<br /><br>- (In)direct medical and non-medical costs, quality adjusted life years (QALY) (Methods described under CEA and BIA. See below)<br /><br>- Anastomotic leakage rate at 30 days follow up through LHCR registration and medical chart review.<br /><br>- Incisional hernia rate by medical chart review (diagnosed by either physical examination and/or ultrasonography or CT) one year after surgery.