Ireland
--:--IST
Active, not recruiting Not applicable

Cost-Effectiveness of Retromuscular Hernia Repair

NCT07530159 · tracked via the Priya Life Science Spain tracker
Sponsor
Fátima Hinojosa Ramírez
Phase
Not applicable
Started
2026-01-01
Last updated
2026-04-15

Condition(s) studied

Ventral Hernia Repair

Investigational drug(s) / intervention(s)

Retromuscular ventral hernia repairPolypropylene meshStandard perioperative care

Retromuscular 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.

Polypropylene mesh: Retromuscular transabdominal hernia repair with polypropylene mesh of 30x30 cm

Standard perioperative care: Standard perioperative care including anesthesia, antibiotic prophylaxis, thromboprophylaxis, postoperative analgesia and routine postoperative management according to institutional protocols.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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)

Primary outcome measure(s)

  • Length of hospital stay — From date of surgery until hospital discharge (typically within 30 days postoperative)

Trial sites (1)

FacilityCityRegionStatus
Hospital Universitario Virgen del Rocío Seville Sevilla
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07530159 on ClinicalTrials.gov ↗ ← All trials in Spain