Cost-Effectiveness of Retromuscular Hernia Repair (ECOHERNIA-3)

Fátima Hinojosa Ramírez

Status: Active, not recruiting

Conditions: Ventral Hernia Repair

Treatments: Other: Standard perioperative care; Device: Polypropylene mesh; Procedure: Retromuscular ventral hernia repair

Study type: Interventional

Funder types: Other

Identifiers

NCT07530159

SICEIA-2025-002057

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Open retromuscular repair

Active Comparator group

Description:

Patients undergoing open retromuscular midline ventral hernia repair acording to routine clinical practice

Treatment:

Procedure: Retromuscular ventral hernia repair

Device: Polypropylene mesh

Other: Standard perioperative care

Laparoscopic retromuscular repair

Experimental group

Description:

Patients undergoing laparoscopic retromuscular midline ventral hernia repair acording to routine clinical practice

Treatment:

Procedure: Retromuscular ventral hernia repair

Device: Polypropylene mesh

Other: Standard perioperative care

Robotic retromuscular repair

Experimental group

Description:

Patients undergoing robotic retromuscular midline ventral hernia repair acording to routine clinical practice

Treatment:

Procedure: Retromuscular ventral hernia repair

Device: Polypropylene mesh

Other: Standard perioperative care