The PRESSURE Trial
Recruiting
- Conditions
- Incisional herniaVentral herniaSurgical site occurrencesPostoperative wound complicationsSurgical site infectionContaminatedContaminationLittekenbreukHerniaPostoperatieve wondcomplicatiesPostoperatieve wondinfectieGecontamineerdContaminatie
- Registration Number
- NL-OMON22141
- Lead Sponsor
- Academic Medical Center, Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 388
Inclusion Criteria
• ≥18 years
• Informed consent
Exclusion Criteria
• Patients <18
• Parastomal hernias in which the stoma is not being relocated or taken down and the parastomal hernia is the only defect planned for reconstruction*
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of patients with at least one clinically relevant surgical site occurrence (SSO) within 30 days after surgery. <br /><br><br /><br>Clinically relevant surgical site occurrences are defined as:<br /><br><br /><br>Surgical site infection<br /><br>Wound cellulitis<br /><br>Wound dehiscence <br /><br>Enterocutaneous fistula<br /><br>Seroma<br /><br>Hematoma<br /><br>Skin ischemia/necrosis<br /><br><br /><br>*A SSO is considered clinically relevant when the attending physician considers the SSO of being of such severity that it needs further action for purposes of clinical diagnosis (other than clinical examination) or treatment, such as ultrasound/CT, antibiotics, drainage or surgery. The term attending physician” is interpreted to mean the surgeon(s), infectious disease specialist, other physician on the case, emergency physician or physician’s designee (nurse practitioner or physician’s assistant).
- Secondary Outcome Measures
Name Time Method -QoL (EQ-5D-5L)<br /><br>-Recurrence 1 year after surgery<br /><br>-The individual components of primary outcome SSO at <30, <90, <1 year after surgery <br /><br>-Peri-incisional SSO <br /><br>-The percentage of patients with signs of SSO on photographs by blinded outcome assessment<br /><br>-Frequency and type of procedures related to SSO <br /><br>-Hospital stay after surgery in days<br /><br>-Earlier removal of iNPWT because of SSO<br /><br>-Emergency department visits after discharge<br /><br>-Readmission within 30 days, 90 days and within a year for any complication<br /><br>-30-day, 90-day, in-hospital and 1-year mortality<br /><br>-Non-primary outcome complications (e.g. ileus, pneumonia)<br /><br>-Cost-effectiveness (The Netherlands only)