Ventral Hernia Repair
Conditions
Brief summary
This prospective observational study aims to evaluate the clinical outcomes and cost-effectiveness of retromuscular midline ventral hernia repair using open, laparoscopic and robotic approaches. Patients undergoing elective repair are included and followed to assess postoperative complications, length of hospital stay, recurrence and quality of life. In addition, a cost-effectiveness analysis will be performed from the perspective of the Spanish National Health System. The study is currently ongoing.
Interventions
PROCEDURERetromuscular ventral hernia repair
Retromuscular ventral hernia repair involves dissection of the retromuscular space, closure of the hernia defect and placement of a mesh in the retromuscular position. The procedure may be performed using an open, laparoscopic or robotic approach according to surgical practice. Differences between approaches relate to access, visualization and instrumentation, while maintaining the same anatomical plane of repair.
DEVICEPolypropylene mesh
Retromuscular transabdominal hernia repair with polypropylene mesh of 30x30 cm
Standard perioperative care including anesthesia, antibiotic prophylaxis, thromboprophylaxis, postoperative analgesia and routine postoperative management according to institutional protocols.
Sponsors
Fátima Hinojosa Ramírez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults ≥ 18 years * Patients scheduled for elective retromuscular repair of midline ventral hernia * Primary hernia or recurrent hernia without previous retromuscular repair * Hernia defect width between 5 and 12 cm (EHS W2-W3) * Ability to understand the study and provide informed consent
Exclusion criteria
* Contraindication to general anesthesia * Contraindication to minimally invasive or open surgery * Body mass index (BMI) \> 35 kg/m² * ASA physical status \> IV * Previous retromuscular hernia repair * Lateral or parastomal hernias * Emergency surgery * Advanced disease with life expectancy \< 2 years * Pregnancy or planned pregnancy during follow-up * Conditions significantly affecting wound healing or surgical risk (e.g., severe immunosuppression, active chemotherapy, connective tissue disorders)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of hospital stay | From date of surgery until hospital discharge (typically within 30 days postoperative) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications (Clavien-Dindo grade ≥ II) | Postoperative complications (Clavien-Dindo grade ≥ II) within 30 days | — |
| Hernia recurrence | 12 months | — |
| Health-related quality of life (EQ-5D-5L) | Health-related quality of life (EQ-5D-5L) at 6 and 12 months | Health-related quality of life measured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The EQ-5D-5L index ranges from values below 0 (worse than death) to 1 (full health), with higher scores indicating netter quality of life. |
| Cost-effectiveness (ICER) | Cost-effectiveness (ICER) at 12 months | — |
| Postoperative pain (VAS) | Postoperative pain (VAS) at 24 hours postoperatively and at hospital discharge (within 30 days after surgery) | Postoperative pain measured using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores including grater pain intensity |
Countries
Spain
Outcome results
None listed