oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias (PRIOR)
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Details and patient eligibility
About
This study investigates on the effect of two different operative techniques to treat large abdominal wall defects.
The goal of this clinical trial is to learn if the minimally-invasive, robotically-assisted ventral hernia repair (RVHR) leads to a better outcome than the open ventral hernia repair (OVHR).
The main questions it aims to answer are:
length of stay after the operation rate of complications rate of recurrence and reoperations quality of life.
Participants will:
Either be operated using the RVHR or OVHR will be followed up either in person or via email / phone call at day 7, day 30, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Patient age >18 years
- Informed consent obtained
- Transverse diameter of ventral hernia >4cm - 15cm
- Eligible to open and minimally-invasive surgery according to preoperative anaesthetic assessment
Exclusion criteria
- precedent hernia treatment with mesh placement in the retromuscular space
- precedent anterior or posterior component separation or transversus abdominis release (TAR)
- active wound infection
- current cancer diagnosis
- presence of ileostomy, colostomy or ileal conduit
- liver disease defined by the presence of ascites
- end-stage renal disease requiring dialysis
- need of an emergency surgery
- pregnancy
Criteria for participating surgeons Each participating surgeon has performed 20 or more OVHR and RVHR.
Trial design
Primary purpose
Allocation
Interventional model
Masking
140 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Fiorenzo Angehrn, MD
Data sourced from clinicaltrials.gov
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